Identity
- Trade Name
- API® LISTERIA EUDAMEDFDA UDI
- Generic Name
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
- Device Name
- API® LISTERIA EUDAMEDAPI® Listeria is a standardized system for the identification of Listeria, which uses miniaturized tests, as well as a database FDA UDI
- Model / Reference
- 10300 EUDAMEDFDA UDI
- Description
- API® Listeria is a standardized system for the identification of Listeria, which uses miniaturized tests, as well as a database FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026035587 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000036SX EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080299 MANUAL IDENTIFICATION - OTHER EUDAMED
- GMDN Term
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
Api® Listeria by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 23a66a89-7dac-4f40-8811-c64f389603e1 34 fields · synced Jul 28, 2026
- EUDAMED 5f73fd8a-cd8b-409c-8305-e327604200fe 61 fields · synced Jul 28, 2026