Tissue-Tek Genie® Advanced Staining Reagents

Quality is US - How we ensure optimal stain quality and scores for each antibody

Laboratories are looking for staining slides with IHC assays that provide high sensitivity and high specificity to maximize diagnostic utility. Furthermore, they request consistent stain quality, slide after slide, especially important to always correctly detect low expressors. We devote our resources to produce reagents that always deliver optimal performance with a lot to lot consistency.

We have designed and implemented a straight forward process to develop robust assays with the following steps:
• Define the intended use and diagnostic utility of the assay
• Determine adequate control material
• Define acceptance criteria
• Identify best clone candidates
• Selection for each the best antigen retrieval
• Define for each the best dilution of the antibody and the incubation times for all the steps of the factory validated protocol
• Validate diagnostic performance internally and externally

Like NordiQC, a professional and scientific organization that promotes the quality of immunohistochemistry and expands its clinical use by arranging schemes for immunohistochemical proficiency testing, we publish the results from our validation studies on our own website called Advanced Staining Gallery to display assay performance scored optimal and enable laboratories to appreciate our daily work for you with full transparency.

We collaborate with a proficiency testing institute for external independent review and confirmation of successful fulfillment of the assessment and acceptance criteria, and for confirmation that the assay performance was scored optimal. As an example, please see the assessment / acceptance criteria for PMS2 applied and explained to the right.

The Sakura Finetek USA antibody-based assay and default protocol run on the Sakura Finetek instrument achieved optimal score by NordiQC in the latest assessment run 53 in 2018 published on their website.
0008232-01_RevB-Broch_TT_Genie_Reagents_print_v14-(5).jpg At least weak to moderte, distinct nuclear staining reaction of virtually all cells in the appendix.
2-(3).bmp A moderate to strong, distinct nuclear staining raction of virtually all neoplastic cells in the colon adenocarcinoma.
3-(1).bmp At least weak to moderate, distinct nuclear staining reaction of virtually all mantle zone B-cells and a moderate to strong, distinct nuclear staining reaction of the germinal center B-cells in the tonsil.
4-(1).bmp No nuclear staining reaction of the neoplastic cells in the colon adenocarcinomas, but a weak to moderate distinct nuclear staining reaction in the vast majority of other cells (stromal cells, lymphocytes etc.).


 
The innovative single-use Capsules make Genie the most convenient stainer on the market, eliminating batching and sorting of slides, and giving you the flexibility to load any slide, any stain, any time, any station on any Genie.

Genie.bmp

Benefit from using Capsules:
1. Run cases or single slides without the need to batch slides by antibody
2. Save time loading slides whenever a staining station is available
3. Use for any slide volume of any biomarkers

The capsule is mounted to the Tissue-Tek Genie® Reagent Dispense Area (RDA) with its attached protocol RDA-Tag and both are loaded into an empty stain station.

Capsules.jpg

In summary, this innovative technology enables laboratories to quickly load slides and reagents for an IHC stain to gain continuous workflow with short and predictable TAT.

 
Sakura Finetek offers high quality primary antibodies and probes specifically developed to provide high sensitivity and specificity when used with the Tissue-Tek Genie Advanced Staining System. This ensures that users are provided with consistent, quality staining results and reproducibility that clinical laboratories have come to expect from Sakura Finetek IHC & ISH advanced staining products.  These staining results were independently evaluated by a leading quality assurance organization to maximize diagnostic utility and provide optimal stain quality.

 
Tissue-Tek Genie<sup>®</sup> anti-Actin, Smooth Muscle

Tissue-Tek Genie® anti-Actin, Smooth Muscle

Clone: 1A4
Host clonality: mouse monoclonal
Control tissue: stomach, small Intestine, colon, appendix, myogenic tumors with know alpha actin expression
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8292-C010: RTU, 10 capsules; 1 pack
8292-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-ALK (Heme)

Tissue-Tek Genie® anti-ALK (Heme)

Clone: 1A4
Host clonality: mouse monoclonal
Control tissue: appendix, ALK positive ALCL
Staining pattern: cytoplasmic and/or nuclear staining
Regulatory status: IVD, FDA Class I
Product code: 8350-C010: RTU, 10 capsules; 1 pack
8350-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-AMACR

Tissue-Tek Genie® anti-AMACR

Clone: 13H4
Host clonality: rabbit monocolonal
Control tissue: prostate adenocarcinoma
Staining pattern: granular and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8291-C010: RTU, 10 capsules; 1 pack
8291-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-BCL2

Tissue-Tek Genie® anti-BCL2

Clone: EP36
Host clonality: Rabbit monoclonal
Control tissue: Tonsil
Staining pattern: Cytoplasmic
Regulatory status:
Product code: 8459-C010: RTU, 10 capsules; 1 pack
8459-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-BCL6

Tissue-Tek Genie® anti-BCL6

Clone: EP278
Host clonality: rabbit monoclonal
Control tissue: tonsil, some B-cell lymphomas
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8461-C010: RTU, 10 capsules; 1 pack
8461-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-beta-Catenin

Tissue-Tek Genie® anti-beta-Catenin

Clone: EP35
Host clonality: rabbit monoclonal
Control tissue: liver, appendix, colon adenocarcinoma, fibromatosis lesions
Staining pattern: nuclear, cytoplasmic, and membraneous
Regulatory status: IVD, FDA Class I
Product code: 8261-C010: RTU, 10 capsules; 1 pack
8261-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-BOB.1

Tissue-Tek Genie® anti-BOB.1

Clone: ZM74
Host clonality: mouse monoclonal
Control tissue: tonsil, DLBCL, follicle center lymphoma
Staining pattern: cytoplasmic and nuclear
Regulatory status: IVD, FDA Class I
Product code: 8462-C010: RTU, 10 capsules; 1 pack
8462-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Calponin

Tissue-Tek Genie® anti-Calponin

Clone: EP63
Host clonality: rabbit monoclonal
Control tissue: gastrointestinal tract, normal breast
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8310-C010: RTU, 10 capsules; 1 pack
8310-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Calretinin

Tissue-Tek Genie® anti-Calretinin

Clone: RM324
Host clonality: rabbit monoclonal
Control tissue: appendix, colon, mesothelioma
Staining pattern: cytoplasmic and nuclear
Regulatory status: IVD, FDA Class I
Product code: 8522-C010: RTU, 10 capsules; 1 pack
8522-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD1a

Tissue-Tek Genie® anti-CD1a

Clone: EP80
Host clonality: rabbit monoclonal
Control tissue: thymus, skin
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8246-C010: RTU, 10 capsules; 1 pack
8246-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD2

Tissue-Tek Genie® anti-CD2

Clone: EP222
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, some T-cell lymphomas
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8255-C010: RTU, 10 capsules; 1 pack
8255-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD3

Tissue-Tek Genie® anti-CD3

Clone: EP177
Host clonality: rabbit monoclonal
Control tissue: tonsil
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8280-C010: RTU, 10 capsules; 1 pack
8280-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD4

Tissue-Tek Genie® anti-CD4

Clone: EP204
Host clonality: rabbit monocolonal
Control tissue: tonsil, appendix, and some T-cell lymphomas
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8226-C010: RTU, 10 capsules; 1 pack
8226-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD5

Tissue-Tek Genie® anti-CD5

Clone: EP132
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, colon
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8251-C010: RTU, 10 capsules; 1 pack
8251-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD7

Tissue-Tek Genie® anti-CD7

Clone: EP132
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, colon
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8251-C010: RTU, 10 capsules; 1 pack
8251-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD8

Tissue-Tek Genie® anti-CD8

Clone: C8/144B
Host clonality: mouse monoclonal
Control tissue: normal tonsil, spleen
Staining pattern: mainly membraneous
Regulatory status: IVD, FDA Class I
Product code: 8252-C010: RTU, 10 capsules; 1 pack
8252-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD10

Tissue-Tek Genie® anti-CD10

Clone: GM003
Host clonality: mouse monoclonal
Control tissue: normal tonsil, small intestine
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8253-C010: RTU, 10 capsules; 1 pack
8253-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD13

Tissue-Tek Genie® anti-CD13

Clone: EP117
Host clonality: rabbit monoclonal
Control tissue: appendix, bone marrow, liver and selected cases of AML
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8503-C010: RTU, 10 capsules; 1 pack
8503-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD14

Tissue-Tek Genie® anti-CD14

Clone: EP128
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, liver
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8321-C010: RTU, 10 capsules; 1 pack
8321-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD15

Tissue-Tek Genie® anti-CD15

Clone: MMA
Host clonality: mouse monoclonal
Control tissue: tonsil, appendix, kidney, classical Hodgkin lymphoma, and lunch adenocarcinoma
Staining pattern: cytoplasmic and membraneous
Regulatory status: IVD, FDA Class I
Product code: 8256-C010: RTU, 10 capsules; 1 pack
8256-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD19

Tissue-Tek Genie® anti-CD19

Clone: EP169
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, and B-cell neoplasms
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8516-C010: RTU, 10 capsules; 1 pack
8516-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD20

Tissue-Tek Genie® anti-CD20

Clone: L26
Host clonality: mouse monoclonal
Control tissue: tonsil
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8259-C010: RTU, 10 capsules; 1 pack
8259-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD21

Tissue-Tek Genie® anti-CD21

Clone: EP64
Host clonality: rabbit monoclonal
Control tissue: tonsil, lymph node
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8260-C010: RTU, 10 capsules; 1 pack
8260-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD23

Tissue-Tek Genie® anti-CD23

Clone: GR013
Host clonality: rabbit monoclonal
Control tissue: tonsil or known CD23 positive B-cell lymphoma
Staining pattern: membraneous and some cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8262-C010: RTU, 10 capsules; 1 pack
8262-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD30

Tissue-Tek Genie® anti-CD30

Clone: Ber-H2
Host clonality: mouse monoclonal
Control tissue: Hodgkin lymphoma and ALCL
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8265-C010: RTU, 10 capsules; 1 pack
8265-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD31

Tissue-Tek Genie® anti-CD31

Clone: RM247
Host clonality: rabbit monoclonal
Control tissue: appendix, tonsil, liver, placenta
Staining pattern: mainly membraneous and some cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8282-C010: RTU, 10 capsules; 1 pack
8282-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD34

Tissue-Tek Genie® anti-CD34

Clone: QBEnd/10
Host clonality: mouse monoclonal
Control tissue: normal appendix, tonsil, liver
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8268-C010: RTU, 10 capsules; 1 pack
8268-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD38

Tissue-Tek Genie® anti-CD38

Clone: GM038
Host clonality: mouse monoclonal
Control tissue: appendix, myeloma, and plasmacytoma
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8277-C010: RTU, 10 capsules; 1 pack
8277-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD43

Tissue-Tek Genie® anti-CD43

Clone: DF-T1
Host clonality: mouse monoclonal
Control tissue: lymph node, tonsil, appendix
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8279-C010: RTU, 10 capsules; 1 pack
8279-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD45

Tissue-Tek Genie® anti-CD45

Clone: GR009
Host clonality: rabbit monoclonal
Control tissue: tonsil, liver
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8271-C010: RTU, 10 capsules; 1 pack
8271-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD56

Tissue-Tek Genie® anti-CD56

Clone: MRQ-42
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, liver
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8274-C010: RTU, 10 capsules; 1 pack
8274-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD57

Tissue-Tek Genie® anti-CD57

Clone: NK1
Host clonality: mouse monoclonal
Control tissue: lymph node and tonsil
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8338-C010: RTU, 10 capsules; 1 pack
8338-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD61

Tissue-Tek Genie® anti-CD61

Clone: ZM33
Host clonality: mouse monoclonal
Control tissue: bone marrow, AML
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8518-C010: RTU, 10 capsules; 1 pack
8518-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD63

Tissue-Tek Genie® anti-CD63

Clone: EP211
Host clonality: rabbit monoclonal
Control tissue: pancreas, skin, prostate, melanoma
Staining pattern: cytoplasmic (with occasional dot-like pattern) and membraneous
Regulatory status: IVD, FDA Class I
Product code: 8283-C010: RTU, 10 capsules; 1 pack
8283-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD68

Tissue-Tek Genie® anti-CD68

Clone: GR021
Host clonality: rabbit monoclonal
Control tissue: tonsil, brain
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8275-C010: RTU, 10 capsules; 1 pack
8275-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD71

Tissue-Tek Genie® anti-CD71

Clone: EP232
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix liver, placenta, bone marrow, AML-M6
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8322-C010: RTU, 10 capsules; 1 pack
8322-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD79a

Tissue-Tek Genie® anti-CD79a

Clone: GR019
Host clonality: rabbit monoclonal
Control tissue: tonsil, colon, appendix
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8278-C010: RTU, 10 capsules; 1 pack
8278-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD117 (c-kit)

Tissue-Tek Genie® anti-CD117 (c-kit)

Clone: EP10
Host clonality: rabbit monoclonal
Control tissue: appendix, colon, GIST
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8267-C010: RTU, 10 capsules; 1 pack
8267-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD138

Tissue-Tek Genie® anti-CD138

Clone: B-A38
Host clonality: mouse monoclonal
Control tissue: tonsil, appendix, plasmacytoma, and CD138 positive DLBCL
Staining pattern: mainly membraneous and some cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8241-C010: RTU, 10 capsules; 1 pack
8241-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CD163

Tissue-Tek Genie® anti-CD163

Clone: EP324
Host clonality: rabbit monoclonal
Control tissue: tonsil, appendix, liver, CD163 positive dermatofibromas
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8245-C010: RTU, 10 capsules; 1 pack
8245-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CDX2

Tissue-Tek Genie® anti-CDX2

Clone: EP25
Host clonality: rabbit monoclonal
Control tissue: appendix, pancreas
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8285-C010: RTU, 10 capsules; 1 pack
8285-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-CEA

Tissue-Tek Genie® anti-CEA

Clone: COL-1
Host clonality: mouse monoclonal
Control tissue: normal colon
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8225-C010: RTU, 10 capsules; 1 pack
8225-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Chromogranin A

Tissue-Tek Genie® anti-Chromogranin A

Clone: LK2H10
Host clonality: mouse monoclonal
Control tissue: colon, appendix, brain, pancreas, neuroendocrine tumors
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8286-C010: RTU, 10 capsules; 1 pack
8286-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-c-Myc

Tissue-Tek Genie® anti-c-Myc

Clone: EP121
Host clonality: rabbit monoclonal
Control tissue: tonsil, c-Myc positive B-cell lymphoma
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8332-C010: RTU, 10 capsules; 1 pack
8332-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cyclin D1

Tissue-Tek Genie® anti-Cyclin D1

Clone: EP12
Host clonality: rabbit monoclonal
Control tissue: tonsil
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8469-C010: RTU, 10 capsules; 1 pack
8469-M250: RTU, 1 cartridge, 250 tests; 1unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 19

Tissue-Tek Genie® anti-Cytokeratin 19

Clone: A53-B/A2.26
Host clonality: mouse monocolnal
Control tissue: tonsil, esophagus, prostate
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8303-C010: RTU, 10 capsules; 1 pack
8303-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 20

Tissue-Tek Genie® anti-Cytokeratin 20

Clone: Ks20.8
Host clonality: mouse monocolonal
Control tissue: normal colon
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8304-C010: RTU, 10 capsules; 1 pack
8304-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin Antibody Cocktail [AE1/AE3]

Tissue-Tek Genie® anti-Cytokeratin Antibody Cocktail [AE1/AE3]

Clone: AE1/AE3
Host clonality: mouse monoclonal
Control tissue: normal liver, esophagus, lung
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8307-C010: RTU, 10 capsules; 1 pack
8307-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin HMW

Tissue-Tek Genie® anti-Cytokeratin HMW

Clone: 34bE12
Host clonality: Mouse monoclonal
Control tissue: tonsil, esophagus, prostate
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8306-C010: RTU, 10 capsules; 1 pack
8306-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin HMW (CK5)

Tissue-Tek Genie® anti-Cytokeratin HMW (CK5)

Clone: GM028
Host clonality: mouse monoclonal
Control tissue: tonsil, esophagus, prostate
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8294-C010: RTU, 10 capsules; 1 pack
8294-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 5/6

Tissue-Tek Genie® anti-Cytokeratin 5/6

Clone: D5/16B4
Host clonality: mouse monoclonal
Control tissue: tonsil, esophagus, prostate
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8295-C010: RTU, 10 capsules; 1 pack
8295-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 7

Tissue-Tek Genie® anti-Cytokeratin 7

Clone: OV-TL 12/30
Host clonality: mouse monoclonal
Control tissue: normal pancreas
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8296-C010: RTU, 10 capsules; 1 pack
8296-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 8

Tissue-Tek Genie® anti-Cytokeratin 8

Clone: EP17
Host clonality: rabbit monoclonal
Control tissue: liver, gastrointestinal tract, and known CK8 positive tumors
Staining pattern: cytoplasmic and sometimes membraneous
Regulatory status: IVD, FDA Class I
Product code: 8238-C010: RTU, 10 capsules; 1 pack
8238-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin LMW (CK8/18) Antibody Cocktail [EP17/DC10]

Tissue-Tek Genie® anti-Cytokeratin LMW (CK8/18) Antibody Cocktail [EP17/DC10]

Clone: EP17/DC10
Host clonality: rabbit and mouse monoclonal
Control tissue: liver, GI tract, esophagus, and known cytokeratin LMW (CK8/18) positive tumors
Staining pattern: cytoplasmic and sometimes membraneous
Regulatory status: IVD, FDA Class I
Product code: 8298-C010: RTU, 10 capsules; 1 pack
8298-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin 14

Tissue-Tek Genie® anti-Cytokeratin 14

Clone: LL002
Host clonality: mouse monoclonal
Control tissue: tonsil, esophagus, prostate, and squamous cell carcinoma
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8300-C010: RTU, 10 capsules; 1 pack
8300-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>® </sup>anti-Cytokeratin 18

Tissue-Tek Genie® anti-Cytokeratin 18

Clone: DC10
Host clonality: mouse monoclonal
Control tissue: liver, gastrointestinal tract, and known CK 18 positive tumors
Staining pattern: cytoplasmic and sometimes membraneous
Regulatory status: IVD, FDA Class I
Product code: 8302-C010: RTU, 10 capsules; 1 pack
8302-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Cytokeratin Pan Antibody Cocktail [AE1/AE3/DC10]

Tissue-Tek Genie® anti-Cytokeratin Pan Antibody Cocktail [AE1/AE3/DC10]

Clone: AE1/AE3/DC10
Host clonality: antibody cocktail
Control tissue: normal liver, esophagus, lung
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8309-C010: 10 capsules, RTU; 1 pack
8309-M250: 1 cartridge, 250 tests, RTU; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Desmin

Tissue-Tek Genie® anti-Desmin

Clone: GM007
Host clonality: mouse monoclonal
Control tissue: intestine
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8311-C010: RTU, 10 capsules; 1 pack
8311-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Desmin

Tissue-Tek Genie® anti-Desmin

Clone: GM007
Host clonality: mouse monoclonal
Control tissue: intestine
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8311-C010: RTU, 10 capsules; 1 pack
8311-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-DOG1

Tissue-Tek Genie® anti-DOG1

Clone: DOG1.1
Host clonality: mouse monoclonal
Control tissue: appendix, GIST
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8368-C010: RTU, 10 capsules; 1 pack
8368-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-E-Cadherin

Tissue-Tek Genie® anti-E-Cadherin

Clone: GM016
Host clonality: mouse monoclonal
Control tissue: appendix, liver, ductal breast carcinoma
Staining pattern: membraneous
Regulatory status: IVD, FDA Class I
Product code: 8229-C010: RTU, 10 capsules; 1 pack
8229-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Epithelial Cell Adhesion Molecule

Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule

Clone: VU-1D9
Host clonality: mouse monoclonal
Control tissue: normal colon
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8230-C010: RTU, 10 capsules; 1 pack
8230-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Epithelial Membrane Antigen

Tissue-Tek Genie® anti-Epithelial Membrane Antigen

Clone: E29
Host clonality: mouse monoclonal
Control tissue: breast ductal carcinoma
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8233-C010: RTU, 10 capsules; 1 pack
8233-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-ERG

Tissue-Tek Genie® anti-ERG

Clone: EP111
Host clonality: rabbit monoclonal
Control tissue: appendix, tonsil, ERG positive prostate carcinoma
Staining pattern: nucrear
Regulatory status: IVD, FDA Class I
Product code: 8323-C010: RTU, 10 capsules; 1 pack
8323-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Factor XIIIa

Tissue-Tek Genie® anti-Factor XIIIa

Clone: EP292
Host clonality: rabbit monoclonal
Control tissue: skin, gastrointestinal tract, liver, dermatofibroma
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8293-C010: RTU, 10 capsules; 1 pack
8293-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Gastrin

Tissue-Tek Genie® anti-Gastrin

Clone: polyclonal
Host clonality: rabbit polyclonal
Control tissue: stomach, gastrin-secreting neuroendocrine tumor
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class i
Product code: 8314-C010: RTU, 10 capsules; 1 pack
8314-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-GATA3

Tissue-Tek Genie® anti-GATA3

Clone: EP368
Host clonality: rabbit monoclonal
Control tissue: tonsil, kidney, breast
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8242-C010: RTU, 10 capsules; 1 pack
8242-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-GCDFP-15

Tissue-Tek Genie® anti-GCDFP-15

Clone: EP95
Host clonality: rabbit monoclonal
Control tissue: skin, GCDFP-15 positive breast and breast carsinoma
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8325-C010: RTU, 10 capsules; 1 pack
8325-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Glial Fibrillary Acidic Protein (GFAP)

Tissue-Tek Genie® anti-Glial Fibrillary Acidic Protein (GFAP)

Clone: GA-5
Host clonality: mouse monoclonal
Control tissue: brain, ganglia of appendix/GI tract, and astrocytoma
Staining pattern: cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8316-C010: RTU, 10 capsules; 1 pack
8316-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Granzyme B

Tissue-Tek Genie® anti-Granzyme B

Clone: EP230
Host clonality: rabbit monoclonal
Control tissue: spleen, tonsil, selected T-cell lymphomas
Staining pattern: cytoplasmic, granular
Regulatory status: IVD, FDA Class I
Product code: 8234-C010: RTU, 10 capsules; 1 pack
8234-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Helicobacter pylori

Tissue-Tek Genie® anti-Helicobacter pylori

Clone: EP179
Host clonality: rabbit monoclonal
Control tissue: H. pylori infected stomach
Staining pattern: cell wall of H. pylori within the crypts of the stomach mucosa
Regulatory status: IVD, FDA Class I
Product code: 8317-C010: RTU, 10 capsules; 1 pack
8317-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-Hepatocyte Specific Antigen (HEP PAR 1)

Tissue-Tek Genie® anti-Hepatocyte Specific Antigen (HEP PAR 1)

Clone: OCH1E5
Host clonality: mouse monoclonal
Control tissue: liver, HCC
Staining pattern: granular cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8374-C010: RTU, 10 capsules; 1 pack
8374-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-IgA

Tissue-Tek Genie® anti-IgA

Clone: EP170
Host clonality: rabbit monoclonal
Control tissue: tonsil, lymph node, a subset of B-cell neoplasms
Staining pattern: membraneous and cytoplasmic
Regulatory status: IVD, FDA Class I
Product code: 8229-C010: RTU, 10 capsules; 1 pack
8229-M250: RTU, 250 tests, 1 cartridge; 1 unit

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Tissue-Tek Genie<sup>®</sup> anti-HHV8

Tissue-Tek Genie® anti-HHV8

Clone: 13B10
Host clonality: mouse monoclonal
Control tissue: neoplastic cells of KS
Staining pattern: nuclear
Regulatory status: IVD, FDA Class I
Product code: 8378-C010: RTU, 10 capsules; 1 pack
8378-M250: RTU, 1 cartridge, 250 tests; 1 unit

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Tissue-Tek Genie® Pro Detection Kit, DAB

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Product code and quantity

8826-K250: 6 cartridges, 250 tests, RTU; 1 kit

Description

The Tissue-Tek Genie Pro Detection Kit, DAB uses a non-biotin based system to detect and to visualize mouse or rabbit primary antibodies bound to antigens in Formalin-Fixed, Paraffin-Embedded (FFPE) specimen sections.

The detection system uses Protein and Peroxidase blocks to prevent unspecific binding of antibodies to antigens and reactions of endogenous peroxidase with downstream components of the detection system. After blocking, the detection system uses a Link solution that binds to the mouse or rabbit primary antibodies to form a complex with a horse radish peroxidase (HRP) conjugate which increases sensitivity.

The complex is then visualized with the addition of DAB. DAB Intensifier can be used to increase the intensity of
DAB staining.

Components

The detection system kit contains 6 cartridges, one cartridge each of the following:
• Tissue-Tek Genie® Protein Block, 250 tests
• Tissue-Tek Genie® Peroxidase Block, 250 tests
• Tissue-Tek Genie® Link, 250 tests
• Tissue-Tek Genie® Poly HRP-Conjugate, 250 tests
• Tissue-Tek Genie® DAB, 250 tests
• Tissue-Tek Genie® DAB Intensifier, 250 tests

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These 6 images display the exceptional sensitivity (high dynamic range) and superb specificity (no visible non-specific background staining) of the Tissue-Tek Genie Pro Detection Kit, DAB and selected Tissue-Tek Genie antibodies.
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Positive Helicobacter pylori staining in crypts of gastric mucosa, no background staining. Negative staining of colon adenocarcinoma with loss of MLH1 expression, no background staining. Negative staining of colon adenocarcinoma with loss of MSH2 expression, no background staining.
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Negative staining of colon adenocarcinoma with loss of MSH6 expression, no background staining. Negative staining of colon adenocarcinoma with loss of PMS2 expression, no background staining. CK 19 staining in crypt cells of appendix with high dynamic range,
no background staining.


The Tissue-Tek Genie Pro Detection Kit, DAB HRP staining steps provide standardization using RTU components and timing flexibility where needed.

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Tissue-Tek Genie® Pro AP Red Detection Kit

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Product code and quantity

8836-K250: 4 cartridges, 250 tests, RTU; 1 kit

Description

The Tissue-Tek Genie Pro AP Red Detection Kit uses a
non-biotin based system to detect and to visualize mouse and rabbit primary antibodies bound to antigens informalin-fixed, paraffin-embedded (FFPE) specimen sections.

The detection system uses protein block to prevent nonspecific binding of antibodies to antigens with downstream components of the detection system. After blocking, the detection system uses a link solution that binds to the mouse and rabbit primary antibodies to form a complex with an alkaline phosphatase AP-Conjugate. The complex is then visualized with the addition of AP Red.

Components

The detection system kit contains 4 cartridges, one cartridge each of the following:
• Tissue-Tek Genie® Protein Block
• Tissue-Tek Genie® Link
• Tissue-Tek Genie® Poly AP-Conjugate
• Tissue-Tek Genie® AP Red

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These 3 images display the exceptional sensitivity (high dynamic range) and superb specificity (no visible non-specific background staining) of the Tissue-Tek Genie Pro AP Red Detection Kit and selected Tissue-Tek Genie antibodies.
 
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Strong pan melanoma staining of melanoma. Melan-A staining of blue nevus. SOX10 staining of melanoma.


The Tissue-Tek Genie Pro AP Red Detection Kit, staining steps provide standardization using RTU components and timing flexibility where needed.

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Tissue-Tek Genie® DUO Detection Kit

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Product code and quantity

8837-K250: 6 cartridges, 250 tests, RTU; 1 kit

Tissue-Tek Genie® DUO Mouse-DAB/Rabbit-AP Red Dual Detection Kit

The Tissue-Tek Genie® DUO Mouse-DAB/Rabbit-AP Red Dual Detection Kit uses a non-biotin-based system to detect and to visualize mouse and rabbit primary antibodies bound to antigens in FFPE specimen sections.
The detection system uses a protein block to prevent nonspecific binding of antibodies to antigens with downstream components of the detection system. After blocking, mouse and rabbit primary antibodies are applied on the tissue sections simultaneously using prefilled capsules or cartridges. Subsequently, the detection system sequentially applies the Link Mouse solution that binds to mouse primary antibodies and then the Link Rabbit solution that binds to rabbit primary antibodies. This is followed by an application of a cocktail containing a horseradish peroxidase (HRP) conjugate for mouse and an alkaline phosphatase AP-Conjugate for rabbit. The resulting complex is visualized by sequentially applying the diaminobenzidine (DAB) substrate-
chromogen solution, and then by applying the AP Red substrate-chromogen solution, which create colored precipitates at the location of the antigens.

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Tissue-Tek Genie® DUO anti-Melan-A [EP43] /Ki67 [GM010] Antibody Cocktail.
Note that the benign melanocytes are not proliferatively active.
Tissue-Tek Genie® DUO anti-Pan Cytokeratin [AE1/AE3/DC10] / CD31[RM247] Antibody Cocktail.
The combination of these two markers on a single slide is particularly helpful for identifying small foci of carcinoma within lymphatics.
Tissue-Tek Genie® DUO Non-immune Mouse and Rabbit Ig Antibody Cocktail.



 

Sakura