Identity
- Trade Name
- PRAS Anaerobic Enrichment Broth (MTGE BROTH) FDA UDI
- Generic Name
- Enriched broth culture medium IVD FDA UDI
- Device Name
- AS-778 Anaerobic Enrichment Broth (MTGE BROTH) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-778 FDA UDI
- Description
- AS-778 Anaerobic Enrichment Broth (MTGE BROTH) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-778 FDA UDI
- Primary DI / UDI-DI
- 00810048900558 FDA UDI
- FDA Product Code
- KZI FDA UDI
- GMDN Term
- Enriched broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Enriched broth culture medium IVD
PRAS Anaerobic Enrichment Broth (MTGE BROTH) by Anaerobe Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anaerobe Systems
Sources (1)
- FDA UDI b48ff967-9a55-4e01-b5a5-7e9c4d7899f2 36 fields · synced Jun 9, 2026