Duns Number:021192653
Device Description: AS-875 Peptone Yeast Extract Broth with Glucose FA/GLC (PYG FA/GLC) is designed for the de AS-875 Peptone Yeast Extract Broth with Glucose FA/GLC (PYG FA/GLC) is designed for the determination of glucose fermentation by anaerobic bacteria for identification. PYG FA/GLC is recommended for use in identifying gram-negative bacteria within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack.
Catalog Number
AS-875
Brand Name
PRAS Peptone Yeast Extract Broth w/ Glucose FA/GLC (PYG FA/GLC)
Version/Model Number
AS-875
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
7c083659-6897-42cd-8c78-620b42b5a173
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 |