Duns Number:516536641
Device Description: Blood Grouping Reagent, ALBAclone Anti-D delta (Human/Murine Monoclonal IgM/IgM) for slide Blood Grouping Reagent, ALBAclone Anti-D delta (Human/Murine Monoclonal IgM/IgM) for slide and tube techniques.
Catalog Number
-
Brand Name
ALBAclone Anti-D delta
Version/Model Number
Z039U
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
348ce652-5523-4830-9f9b-e88d6955cdb1
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
November 14, 2014
Package DI Number
05060242470912
Quantity per Package
10
Contains DI Package
05060242471506
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |