Duns Number:516536641
Device Description: The Anti-K reagent is for the in vitro detection and identification of the human K blood g The Anti-K reagent is for the in vitro detection and identification of the human K blood group antigen by direct agglutination.
Catalog Number
-
Brand Name
ALBAclone Anti-K (Monoclonal)
Version/Model Number
Z132U
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)
Yes
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
-
Product Code Name
-
Public Device Record Key
a903cd8b-186a-4ee4-8ab2-206b20924a94
Public Version Date
March 31, 2022
Public Version Number
2
DI Record Publish Date
June 27, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |