Identity
- Trade Name
- C. DIFFICILE TOX A/B II FDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FDA UDI
- Model / Reference
- 30397 FDA UDI
- Description
- The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002103 FDA UDI
- 510(k) Number
- K003306 FDA UDI
- FDA Product Code
- LLH FDA UDI
- GMDN Term
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
C. Difficile Tox A/B Ii by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA).
- ImmunoCard C. difficile GDH — MERIDIAN BIOSCIENCE, INC. · Class I
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
- VIDAS® C. difficile Toxin A & B — BIOMERIEUX , INC. · Class I
- ProSpecT C. difficile Toxin A/B Microplate — OXOID LIMITED · Class I
- PREMIER Toxins A and B — MERIDIAN BIOSCIENCE, INC. · Class I
- ImmunoCard Toxins A & B — MERIDIAN BIOSCIENCE, INC. · Class I
- PREMIER C. difficile GDH — MERIDIAN BIOSCIENCE, INC. · Class I
- C. DIFF CHEK - 60 — TECHLAB, INC. · Class I
Cleared under the same submission
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
- Techlab, Inc.
Sources (1)
- FDA UDI 64e12d47-8464-4800-af00-5fe2301b056e 34 fields · synced May 30, 2026