Identity
- Trade Name
- C. DIFF QUIK CHEK COMPLETE FDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history. FDA UDI
- Model / Reference
- 30550C FDA UDI
- Description
- The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002387 FDA UDI
- 510(k) Number
- K082499 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. Diff Quik Chek Complete 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
K082499 also covers:
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 ae7254bc-2c7a-4663-9387-3cd0bdbcff60 34 fields · synced May 30, 2026