Duns Number:516536641
Device Description: Blood Grouping Reagent, ALBAclone Anti-D beta (Human/Murine Monoclonal IgM) for slide and Blood Grouping Reagent, ALBAclone Anti-D beta (Human/Murine Monoclonal IgM) for slide and tube techniques.
Catalog Number
-
Brand Name
ALBAclone Anti-D beta
Version/Model Number
Z036U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
a8ae34e0-fd31-4aa6-8d0c-edc83aa19edc
Public Version Date
March 31, 2022
Public Version Number
5
DI Record Publish Date
November 14, 2014
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 |