Duns Number:342920388
Device Description: BW135/80 recognizes the human CD8 antigen which is strongly expressed on human cytotoxic T BW135/80 recognizes the human CD8 antigen which is strongly expressed on human cytotoxic T cells and thymocytes, and is also expressed on a subset of NK cells. The CD8 antigen is a disulfide-linked dimer that exists either as a CD8 alpha homodimer or as a CD8 alpha/beta heterodimer. CD8 acts as a coreceptor for the T cell receptor and binds to the MHC Class I molecule. The CD8 antibody recognizes the alpha-subunit of the antigen.
Catalog Number
-
Brand Name
CD8-FITC
Version/Model Number
170-081-008
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)
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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
2d9162b5-c1ed-436b-9a6e-d091e5ddf703
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 |