Duns Number:516536641
Device Description: Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
Catalog Number
-
Brand Name
ALBAsure QC Kit
Version/Model Number
Z481U
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
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
b939f7d0-5c9c-40d5-a12b-661ace34d9c7
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
July 15, 2015
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 |