Identity
- Trade Name
- Clostridium difficile (CDF) Amplification Tray FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
- Device Name
- The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). FDA UDI
- Model / Reference
- 20-011-022 FDA UDI
- Description
- The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). FDA UDI
Identifiers
- Catalog Number
- 20-011-022 FDA UDI
- Primary DI / UDI-DI
- 00840487101704 FDA UDI
- 510(k) Number
- K123197 FDA UDI
- FDA Product Code
- OZN FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3130 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
No
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: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Clostridium difficile (CDF) Amplification Tray by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray.
- Stool Bacterial Pathogens Panel — Great Basin Scientific, Inc. · Class II
- Shiga Toxin Direct Test — Great Basin Scientific, Inc. · Class II
- Clostridium difficile (CDF) Extraction Tray — Luminex Corporation · Class II
- Enteric Pathogens (EP) Extraction Tray — Luminex Corporation · Class II
- Clostridium difficile (CDF) Stool Sample Preparation Kit — Luminex Corporation · Class II
- Enteric Pathogens (EP) Nucleic Acid Test Cartridge — Luminex Corporation · Class II
- Clostridium difficile (CDF) Nucleic Acid Test Cartridge — Luminex Corporation · Class II
- Enteric Pathogens (EP) Amplification Tray — Luminex Corporation · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI 723f2fb7-da70-4eec-a635-8a2cee5fe707 37 fields · synced Jun 9, 2026