Duns Number:021192653
Device Description: AS-852 Peptone Yeast Extract Broth with Pyruvic Acid (PY PYRUVIC ACID) is an enriched non- AS-852 Peptone Yeast Extract Broth with Pyruvic Acid (PY PYRUVIC ACID) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilizd (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent golden yellow liquid. 10 tubes per pack.
Catalog Number
AS-852
Brand Name
PRAS Peptone Yeast Extract Broth w/ Pyruvic Acid (PY PYRUVIC ACID)
Version/Model Number
AS-852
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
627a1e78-5482-4fc1-b211-fa64f37fae4b
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 |