Duns Number:516536641
Device Description: ALBAzyme™ Papain Solution Kit is used for the preparation and testing of papainized red bl ALBAzyme™ Papain Solution Kit is used for the preparation and testing of papainized red blood cells.
Catalog Number
-
Brand Name
ALBAzyme™ Papain Solution Kit
Version/Model Number
Z317U
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
KSK
Product Code Name
Solution, Stabilized Enzyme
Public Device Record Key
b7c3e3df-22cd-48ac-b059-41e42d384203
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
March 29, 2017
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 |