Duns Number:516536641
Device Description: This Anti-D reagent is for the in vitro detection and identification of human RhD blood gr This Anti-D reagent is for the in vitro detection and identification of human RhD blood group status in patient and donor samples by direct agglutination and the indirect antiglobulin test.
Catalog Number
-
Brand Name
ALBAclone Anti-D fusion
Version/Model Number
Z043U
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
97c6faf4-9e3f-47a5-8016-5e4797ed1ea9
Public Version Date
March 31, 2022
Public Version Number
3
DI Record Publish Date
October 24, 2018
Package DI Number
05060242471827
Quantity per Package
10
Contains DI Package
05060242471797
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |