Identity
- Trade Name
- VIDAS® C. difficile Toxin A & B EUDAMEDFDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS® C. difficile Toxin A & B EUDAMEDThe VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens FDA UDI
- Model / Reference
- 30118 EUDAMED30118-01 FDA UDI
- Description
- The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026064204 EUDAMED03573026229146 FDA UDI
- Basic UDI-DI
- 357302BUDI000587U9 EUDAMED
- 510(k) Number
- K080931 FDA UDI
- FDA Product Code
- LLH FDA UDI
- EMDN Code
- W0105011802 C.DIFFICILE TOXIN A/B DETECTION EUDAMED
- GMDN Term
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
VIDAS® C. difficile Toxin A & B 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 d422473d-7b74-4254-8f22-116dc9c52595 35 fields · synced Jul 29, 2026
- EUDAMED 2dd1e9cd-e92d-4467-aced-16bb16ba6cb9 61 fields · synced Jul 29, 2026