Duns Number:342920388
Device Description: 5B1 recognizes the human CD45 antigen, a tyrosine phosphatase also known as the leukocyte 5B1 recognizes the human CD45 antigen, a tyrosine phosphatase also known as the leukocyte common antigen (LCA). The CD45 molecule is required for T and B cell activation and is expressed in at least five isoforms depending on the differentiation status of the cell. The CD45 antibody recognizes a common epitope of all CD45 isoforms.
Catalog Number
-
Brand Name
CD45-VioBlue (Clone 5B1)
Version/Model Number
170-081-012
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
5d7e8039-b35d-44a5-8985-e390e9d1d6f1
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 |