Duns Number:342920388
Device Description: BW242/412 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor (TCR) BW242/412 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor (TCR) is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. Both 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. The Anti-TCRalpha/beta antibody, BW242/412, recognizes a common determinant of the TCRalpha/beta-CD3 complex.
Catalog Number
-
Brand Name
Anti-TCRa/b-PE (Clone BW242/412)
Version/Model Number
170-081-005
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
5d7950eb-105b-43f8-9f40-fb981cc262b3
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 |