FDA UDI Not in Commercial Distribution 🇺🇸 United States

PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC

DI: 00810048901142 · Model: AS-858 · ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

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Basic Information

Brand Name
PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC
Primary DI
00810048901142
Version / Model
AS-858
Catalog Number
AS-858
Company Name
ANAEROBE SYSTEMS
Labeler DUNS
021192653
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2020-05-01
Public Version
3
Public Version Date
2021-12-31
Public Version Status
Update
Public Device Record Key
24cbeb97-d232-4786-9756-0016beb4dc08
Distribution End Date
2021-12-31

Device Description

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.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JSC Culture Media, General Nutrient Broth

GMDN Terms

Code Name
58586 Basic/simple nutrient broth culture medium IVD

Identifiers

Type ID
Unit of Use 00810048902293
Primary 00810048901142

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
20 – 25 Degrees Celsius