Duns Number:039981550
Device Description: Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, shatter resistant, polycarbonate tube, 20 per kitUsed for the preparation of specimens for AFB culture. A growth stimulant for Mycobacterium tuberculosis.
Catalog Number
Z81
Brand Name
N/A
Version/Model Number
Z81
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
JSK
Product Code Name
Supplement, Culture Media
Public Device Record Key
583e349c-2591-45cb-a48e-f25c1b4da189
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 2020
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |