Identity
- Trade Name
- PRAS Peptone Yeast Extract Broth (PY) FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- AS-8212 Peptone Yeast Extract Broth (PY) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilized (PRAS).250 mL fill volume. 250 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack. FDA UDI
- Model / Reference
- AS-8212 FDA UDI
- Description
- AS-8212 Peptone Yeast Extract Broth (PY) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilized (PRAS).250 mL fill volume. 250 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack. FDA UDI
Identifiers
- Catalog Number
- AS-8212 FDA UDI
- Primary DI / UDI-DI
- 00810048901401 FDA UDI
- FDA Product Code
- JSC FDA UDI
- GMDN Term
- Basic/simple nutrient broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2350 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: Basic/simple nutrient broth culture medium IVD
PRAS Peptone Yeast Extract Broth (PY) by Anaerobe Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic/simple nutrient broth culture medium IVD.
- Microbank Broth Only -Red (80 vials) — PRO-LAB, INCORPORATED · Class I
- Microbank Dry - Green (80 vials) — PRO-LAB, INCORPORATED · Class I
- BACT/ALERT® FA — BIOMERIEUX , INC. · Class I
- BACT/ALERT® SA — BIOMERIEUX , INC. · Class I
- EDGE BIOLOGICALS INC — Edge Biologicals, Inc. · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- BACT/ALERT® BPN — BIOMERIEUX , INC. · Class I
- BACT/ALERT® — BIOMERIEUX , INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anaerobe Systems
Sources (1)
- FDA UDI 7469cc03-9efd-42b6-931f-de224e843d07 36 fields · synced Jun 9, 2026