Duns Number:342920388
Device Description: TB03 recognizes the human CD57. CD57, also known as HNK-1 or Leu-7, is an antigenic Oligos TB03 recognizes the human CD57. CD57, also known as HNK-1 or Leu-7, is an antigenic Oligosaccharide moiety detected on extracellular proteins of certain cell types. In blood, CD57 is found on 15-20% of mononuclear cells, including subsets of NK and T cells, though not on erythrocytes, monocytes, granulocytes, or platelets. Also, CD57 expression can be found on a variety of neural cell types. CD57 has been shown to be expressed on late stage effector CD8+ T cells. The frequency of CD57+ T lymphocytes is raised in a variety of diseases. CD57 expression is also increased on chronically activated CD8+ T cells in persistent viral infections, such as HIV.
Catalog Number
-
Brand Name
CD57-FITC
Version/Model Number
170-081-025
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
b4f24102-80ff-48d6-a1ee-7258d81538ab
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 |