Duns Number:342920388
Device Description: REA734 recognizes the human CD8 antigen, a cell-surface glycoprotein also known as Leu-2 o REA734 recognizes the human CD8 antigen, a cell-surface glycoprotein also known as Leu-2 or CD8a. CD8 is strongly expressed on human cytotoxic T cells and thymocytes as well as on a subset of NK cells. The CD8 antigen is a disulfide-linked dimer that exists either as a CD8a homodimer or as a CD8alpha/beta heterodimer. CD8 acts as a co-receptor for the T cell receptor and binds to the MHC class I molecules. CD8 is involved in T cell development and activation of mature T cells. The CD8 antibody recognizes the alpha-subunit of the antigen. Additional information: Clone REA734 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD8-APC-Vio770 (Clone REA734)
Version/Model Number
170-081-075
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
11d5736f-0562-4a1d-9b84-f95af077b3e2
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 88 |