Duns Number:061446282
Device Description: GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. G GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
Catalog Number
0007058
Brand Name
GammaZyme-B
Version/Model Number
0007058
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK880016
Product Code
KSK
Product Code Name
Solution, Stabilized Enzyme
Public Device Record Key
9d5f0920-74a5-4b75-9b85-8752715c8602
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 15, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |