Duns Number:516536641
Device Description: Bovine Serum Albumin 22%.
Catalog Number
-
Brand Name
Bovine Serum Albumin 22%
Version/Model Number
Z305U
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
KSG
Product Code Name
Media, Potentiating For In Vitro Diagnostic Use
Public Device Record Key
1d96ee52-c0b9-465c-b701-cc97ae12ad65
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
November 14, 2014
Package DI Number
05060242471094
Quantity per Package
10
Contains DI Package
05060242471520
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |