Identity
- Trade Name
- PYG with POLYSORBATE 10mL EUDAMEDPRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG TWEEN FA/GLC) FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-825 Peptone Yeast Extract Broth with Glucose and Tween 80 FA/GLC (PYG TWEEN FA/GLC) is designed for the determination of glucose fermentation and Tween 80 stimulation by anaerobic bacteria for identification. PYG FA/GLC is recommended for use in identifying gram-positive bacteria within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-825 EUDAMEDFDA UDI
- Description
- AS-825 Peptone Yeast Extract Broth with Glucose and Tween 80 FA/GLC (PYG TWEEN FA/GLC) is designed for the determination of glucose fermentation and Tween 80 stimulation by anaerobic bacteria for identification. PYG FA/GLC is recommended for use in identifying gram-positive bacteria within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-825 FDA UDI
- Primary DI / UDI-DI
- 00810048900763 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 with POLYSORBATE 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 2b6a24e1-7719-40ee-87bc-32255384a100 61 fields · synced Jul 20, 2026
- FDA UDI b481d1ed-4163-4eef-9959-f9c8f841889b 37 fields · synced May 29, 2026