Duns Number:021192653
Device Description: AS-777 Anaerobic Enrichment Agar (MTGE) is an enriched non-selective medium used for the c AS-777 Anaerobic Enrichment Agar (MTGE) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow color. 4 plates per pack.
Catalog Number
AS-777
Brand Name
PRAS Anaerobic Enrichment Agar (MTGE)
Version/Model Number
AS-777
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
KZI
Product Code Name
Culture Media, Enriched
Public Device Record Key
ba3ee496-37e0-40a5-900b-0516467216a4
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 |