Duns Number:894671143
Device Description: MultiMix Dual-Colour Reagent Anti-Human, CD4/FITC Anti-Human CD8/RPE
Catalog Number
-
Brand Name
MultiMix Dual-Colour Reagent A-Hu CD4/FITC, A-Hu CD8/RPE
Version/Model Number
FR868
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"
-
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
GKZ
Product Code Name
Counter, differential cell
Public Device Record Key
cd817374-fc38-4745-94af-51249c17809b
Public Version Date
December 07, 2020
Public Version Number
7
DI Record Publish Date
September 16, 2016
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 | 490 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |
| 3 | A medical device with high risk that requires premarket approval | 5 |