Identity
- Trade Name
- PY with LACTATE 10mL EUDAMEDPRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC) FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-846 Peptone Yeast Extract Broth with Lactate FA/GLC (PY LACTATE FA/GLC) is designed for the determination of lactate fermentation by anaerobic bacteria for identification. PY LACTATE FA/GLC is recommended for use in identifying Veillonella species within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-846 EUDAMEDFDA UDI
- Description
- AS-846 Peptone Yeast Extract Broth with Lactate FA/GLC (PY LACTATE FA/GLC) is designed for the determination of lactate fermentation by anaerobic bacteria for identification. PY LACTATE FA/GLC is recommended for use in identifying Veillonella species within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-846 FDA UDI
- Primary DI / UDI-DI
- 00810048901135 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
PY with LACTATE 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED 19edd8a1-d327-4b38-a4a0-1c73621488bd 61 fields · synced Jul 9, 2026
- FDA UDI 2e3e2e89-c98d-4530-be05-43fb1a086d1c 37 fields · synced May 30, 2026