Duns Number:021192653
Device Description: AS-801 Thioglycollate Broth (THIO) is an enriched nonselective liquid medium used for the AS-801 Thioglycollate Broth (THIO) is an enriched nonselective liquid medium used for the growth of microaerophilic and anaerobic bacteria, including fastidious organisms, from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid with a marble chip. 10 tubes per pack.
Catalog Number
AS-801
Brand Name
PRAS Thioglycollate Broth (THIO)
Version/Model Number
AS-801
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
JSC
Product Code Name
Culture Media, General Nutrient Broth
Public Device Record Key
d7fc402b-da24-4071-ab59-e3b3b855e57d
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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 | 148 |