Identity
- Trade Name
- Xpert C. difficile/Epi FDA UDI
- Generic Name
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert C. difficile/Epi kit; 120 test kit FDA UDI
- Model / Reference
- GXCDIFF/EPI-120 FDA UDI
- Description
- Xpert C. difficile/Epi kit; 120 test kit FDA UDI
Identifiers
- Catalog Number
- GXCDIFF/EPI-120 FDA UDI
- Primary DI / UDI-DI
- 07332940000042 FDA UDI
- 510(k) Number
- K110203 FDA UDI
- FDA Product Code
- OMN FDA UDI
- GMDN Term
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) 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 nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile/Epi by Cepheid — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD MAX™ Cdiff (US) — BECTON DICKINSON AND COMPANY · Class II
- Alethia™ C. difficile — MERIDIAN BIOSCIENCE, INC. · Class I
- Portrait Toxigenic C. difficile Assay — Great Basin Scientific, Inc. · Class II
- Revogene C. difficile — MERIDIAN BIOSCIENCE, INC. · Class II
- Toxigenic C. difficile Direct Test — Vela Operations USA · Class II
- Toxigenic C. difficile Direct Test - Sample Prep — Vela Operations USA · Class II
- Simplexa™ C.difficile Sample Prep Kit — DiaSorin Molecular LLC · Class II
- Lyra — Quidel Corp. · Class II
Cleared under the same submission
K110203 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
- Cepheid
Sources (1)
- FDA UDI b4b6ca4c-c9fa-4d3f-a379-a5c575a361f0 37 fields · synced May 30, 2026