Duns Number:342920388
Device Description: 11F2 recognizes the human gamma/delta T cell receptor (TCR). The T cell receptor is a hete 11F2 recognizes the human gamma/delta T cell receptor (TCR). The T cell receptor is a heterodimeric glycoprotein associated with the CD3 antigen. The TCR consists of a alpha and a beta chain (TCRa/b) or a gamma and a delta chain (TCRg/d). Clone 11F2 reacts with a framework epitope of the gamma/delta T cell–receptor. The gamma and delta TCR chains are composed of constant and variable regions, each encoded by distinct gene segments. The gamma chain forms either disulfide-linked or non-disulfide-linked heterodimers with the delta-subunit. The gamma/delta T cell–receptor is present on a subset of T lymphocytes in peripheral blood, intestinal epithelium, lymph node, thymus, and spleen. TCR gamma/delta is involved in the recognition of certain bacterial, self-CD1 molecule, and tumor antigens bound to MHC class I. Gamma/delta T cells are mainly CD4 negative and CD8 negative. T cells expressing the gamma/delta TCR have been shown to play a role in oral tolerance, innate immune response for some tumor cells, and autoimmune disease. Antigen presentation by gamma/delta T cells has been reported.
Catalog Number
-
Brand Name
Anti-TCRg/d-PE
Version/Model Number
170-081-071
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
39531799-0a86-49bc-9372-8b066a6174e9
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 |