Duns Number:342920388
Device Description: REA652 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor is a het REA652 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. In 95% of T cells the TCR consists of an alpha and beta chain, whereas in 5% of T cells it has gamma and delta chains. Alpha and beta chains are members of the Ig superfamily and consist of a constant and a polymorphic variable region. The variable region of the TCRalpha/beta is involved in recognition of antigenic peptides presented by the MHC complex of antigen-presenting cells. Additional information: Clone REA652 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
Anti-TCRa/b-PE (Clone REA652)
Version/Model Number
170-081-069
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)
-
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
c29eff9b-2afd-4d69-9a91-16016875492d
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 |