Identity
- Trade Name
- PRAS THIOGLYCOLATE MEDIUM (7mL) EUDAMEDPRAS Thioglycollate Broth (THIO) FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-801 Thioglycollate Broth (THIO) is an enriched nonselective liquid medium used for the growth of microaerophilic and anaerobic bacteria, including fastidious organisms, from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid with a marble chip. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-801 EUDAMEDFDA UDI
- Description
- AS-801 Thioglycollate Broth (THIO) is an enriched nonselective liquid medium used for the growth of microaerophilic and anaerobic bacteria, including fastidious organisms, from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid with a marble chip. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-801 FDA UDI
- Primary DI / UDI-DI
- 00810048900589 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- Unit of Use DI
- 00810048901845 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
- 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
PRAS THIOGLYCOLATE MEDIUM (7mL) 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 35b93248-fb4d-4bcd-b688-5e4f2fa16901 61 fields · synced Aug 2, 2026
- FDA UDI d7fc402b-da24-4071-ab59-e3b3b855e57d 36 fields · synced May 29, 2026