Duns Number:342920388
Device Description: VIT4 recognizes the human CD4 antigen which is highly expressed on human T helper cells an VIT4 recognizes the human CD4 antigen which is highly expressed on human T helper cells and thymocytes, and at lower levels on monocytes and dendritic cells. It is responsible for the recognition of the MHC Class II antigen.
Catalog Number
-
Brand Name
CD4-FITC
Version/Model Number
170-081-036
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
fba20d96-994c-4841-b9b6-f99dc3889e5f
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 |