Duns Number:342920388
Device Description: BW264/56 is a monoclonal murine IgG2a antibody, which recognizes the human CD3 antigen pre BW264/56 is a monoclonal murine IgG2a antibody, which recognizes the human CD3 antigen present on mature human T cells, thymocytes, and a subset of NK cells. CD3 is associated with the T cell receptor (TCR) and is responsible for its signal transduction. The CD3 antigen is a complex of five invariable chains: gamma, delta, epsilon, zeta and eta. The epitope recognized by the antibody is located on the epsilon-chain of the CD3 complex.
Catalog Number
-
Brand Name
CD3-APC
Version/Model Number
170-081-006
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
44492732-a713-45da-9e37-73002122d5a8
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 |