Identity
- Trade Name
- Enteric Pathogens (EP) Amplification Tray FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
- Device Name
- The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. FDA UDI
- Model / Reference
- 20-011-023 FDA UDI
- Description
- The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. FDA UDI
Identifiers
- Catalog Number
- 20-011-023 FDA UDI
- Primary DI / UDI-DI
- 00840487101544 FDA UDI
- 510(k) Number
- K140083 FDA UDI
- FDA Product Code
- PCH FDA UDIPCI FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3990 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
Enteric Pathogens (EP) 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
- Clostridium difficile (CDF) 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 5a62a71d-5795-46e8-9911-a5bd5c9cef32 37 fields · synced Jun 9, 2026