Duns Number:021192653
Device Description: AS-858 Peptone Yeast Extract Broth with Glucose and Formate/Fumarate FA/GLC (PYG FF FA/GLC AS-858 Peptone Yeast Extract Broth with Glucose and Formate/Fumarate FA/GLC (PYG FF FA/GLC) is designed for the determination of glucose fermentation and formate/fumarate stimulation by anaerobic bacteria for identification. PYG FF FA/GLC is recommended for use in identifying Campylobacter ureolyticus within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent golden yellow liquid. 10 tubes per pack.
Catalog Number
AS-858
Brand Name
PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC
Version/Model Number
AS-858
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
24cbeb97-d232-4786-9756-0016beb4dc08
Public Version Date
December 31, 2021
Public Version Number
3
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 |