Pras Peptone Yeast Extract Broth W/ Glucose & Formate/Fumarate 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…

Registry build 21.09.26

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.

1manufacturer
2catalogue numbers in this listing
6510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JSC
Manufacturer City Province Registered as Device types
Jiaoyue Pharmaceutical (Huizhou) Co., Ltd. Huizhou Guangdong Manufacturer 9

Record

Regulatory record for Pras Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC
Listed by Anaerobe Systems, United States
FDA product code JSC
Device type Culture Media, General Nutrient Broth
Device class Class 1
Regulation 21 CFR 866.2350
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-05-01
Record revised 2021-12-31 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 20 to 25 °C
Distribution end date 2021-12-31

Catalogue Numbers

Catalogue numbers for Pras Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC
Catalogue number Size Per pack Status
AS-858 10 In distribution
AS-858 10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Edge Biologicals Inc Edge Biologicals, Inc. 32
Culture Media, General Nutrient Broth Hardy Diagnostics 26
Redipor Analytichem USA, Inc. 21
Pras Dilution Blanks Anaerobe Systems 7
Tryptone Soya Broth Oxoid, Ltd. 6
Jiaoyue Jiaoyue Pharmaceuticals (Huizhou) Co., Ltd. 4
Pras Peptone Yeast Extract Broth (PY) Anaerobe Systems 3
Pras Reinforced Clostridial Broth (RCB) Anaerobe Systems 3
Cell Pro Analytichem USA, Inc. 3
Pras Peptone Yeast Extract Broth w/ Glucose (PYG) Anaerobe Systems 3
BD BBL™ Brain Heart Infusion Becton, Dickinson AND Company 3
Pras Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG Tween FA/GLC) Anaerobe Systems 2

Showing 12 of 86. All products under Culture Media, General Nutrient Broth

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K841219 1984-04-04
K841221 1984-04-04
K790625 1979-05-01
K790616 1979-04-23
K790620 1979-04-23
K790619 1979-04-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer