Duns Number:021192653
Device Description: AS-548 Enriched Tryptic Soy Agar (ETSA) is an enriched, non-selective, and differential me AS-548 Enriched Tryptic Soy Agar (ETSA) is an enriched, non-selective, and differential medium intended for the isolation, quantitation, and partial identification of many fastidious and non-fastidious microorganisms. Pre-reduced anaerobically sterilized. 100 x 15 mm agar plate. Transparent yellow/red. 4 plates per pack.
Catalog Number
AS-548
Brand Name
PRAS Enriched Tryptic Soy Agar (ETSA)
Version/Model Number
AS-548
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
69656600-9173-4f35-b2f4-cf39ea30789a
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 |