Identity
- Trade Name
- Revogene® C. difficile FDA UDI
- Generic Name
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI. FDA UDI
- Model / Reference
- 410300 FDA UDI
- Description
- The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI. FDA UDI
Identifiers
- Catalog Number
- 410300 FDA UDI
- Primary DI / UDI-DI
- 00628055344124 FDA UDI
- FDA Product Code
- OZN FDA UDI
- GMDN Term
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3130 FDA UDI
- Commercial Distribution
- Not 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
Revogene® C. difficile by Meridian Bioscience Canada Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience Canada Inc
Sources (1)
- FDA UDI 14b899ec-0be2-41ec-a5f1-8407501df24b 37 fields · synced Jun 1, 2026