Duns Number:342920388
Device Description: T6D11 recognizes the human CD45RA antigen which is expressed on naive CD4+ and CD8+ T cell T6D11 recognizes the human CD45RA antigen which is expressed on naive CD4+ and CD8+ T cells as well as on CD8+ effector T cells. CD45RA is also present on subsets of B and NK cells as well as on plasmacytoid dendritic cells. The CD45RA antibody recognizes the 220 kDa isoform of the leukocyte common antigen (LCA), a transmembrane tyrosine phosphatase.
Catalog Number
-
Brand Name
CD45RA-APC
Version/Model Number
170-081-003
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)
-
FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
90fac894-b447-4e7d-897b-56cc08ab94a8
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 |