Identity
- Trade Name
- PREMIER Toxins A and B FDA UDI
- Generic Name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD). FDA UDI
- Model / Reference
- 616096 FDA UDI
- Description
- Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD). FDA UDI
Identifiers
- Catalog Number
- 616096 FDA UDI
- Primary DI / UDI-DI
- 00840733101694 FDA UDI
- 510(k) Number
- K993914 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)
PREMIER Toxins A and B by Meridian Bioscience, 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).
- C. DIFF CHEK - 60 — TECHLAB, INC. · Class I
- C. DIFF CHEK - 60 — TECHLAB, INC. · Class I
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
- C. DIFF CHEK - 60 — TECHLAB, INC. · Class I
- C. DIFF QUIK CHEK COMPLETE — TECHLAB, INC. · Class I
- C. DIFFICILE TOX A/B II — TECHLAB, INC. · Class I
- C. DIFF QUIK CHEK — TECHLAB, INC. · Class I
- C. DIFF QUIK CHEK COMPLETE — TECHLAB, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 5d33b0fc-d02e-4ddc-be06-829a62339101 37 fields · synced May 30, 2026