Duns Number:516536641
Device Description: ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunc ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU).
Catalog Number
-
Brand Name
ALBAcheck - BGS Monoclonal Control
Version/Model Number
Z271U
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
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
9c2bddbe-8bc4-409e-87f0-51c09e81c4d7
Public Version Date
March 31, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2020
Package DI Number
05060242472459
Quantity per Package
1
Contains DI Package
05060242472473
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 |