Duns Number:342920388
Device Description: REA623 recognizes the human CD4 antigen, a 55 kDa single-pass type I membrane protein, als REA623 recognizes the human CD4 antigen, a 55 kDa single-pass type I membrane protein, also known as T4/Leu-3. CD4 is highly expressed on T helper cells and at a lower level on monocytes and dendritic cells. It is involved in the recognition of MHC class ll/peptide complexes by the TCR heterodimers and is the receptor for the human immunodeficiency virus (HIV). Additional information: Clone REA623 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD4-VioGreen (Clone REA623)
Version/Model Number
170-081-084
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
989e7272-f91b-44a6-95b0-05d009bddc8e
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 |