Duns Number:061446282
Device Description: Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatc Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
Catalog Number
0002327
Brand Name
Bovine Albumin Solution 22%
Version/Model Number
0002327
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
BK830004
Product Code
KSG
Product Code Name
Media, Potentiating For In Vitro Diagnostic Use
Public Device Record Key
7f95da51-d043-41c5-aa04-a30ee3a6d496
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 |