Identity
- Trade Name
- PYG w/FORMATE+FUMARATE 10mL EUDAMEDPRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-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. FDA UDI
- Model / Reference
- AS-858 EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- AS-858 FDA UDI
- Primary DI / UDI-DI
- 00810048901142 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- JSC FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMED
- GMDN Term
- Basic/simple nutrient broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PYG w/FORMATE+FUMARATE 10mL by Anaerobe Systems — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081004890ANAEROBEDT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED b710c7e9-93f7-4725-8534-275a94b82b1e 61 fields · synced Jul 25, 2026
- FDA UDI 24cbeb97-d232-4786-9756-0016beb4dc08 37 fields · synced May 30, 2026