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Respiratory Pathogens Flex (RP Flex) Extraction Tray
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Respiratory Pathogens Flex (RP Flex) Extraction Tray FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. FDA UDI
- Model / Reference
- 20-009-024 FDA UDI
- Description
- The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. FDA UDI
Identifiers
- Catalog Number
- 20-009-024 FDA UDI
- Primary DI / UDI-DI
- 00840487101667 FDA UDI
- 510(k) Number
- K143653 FDA UDI
- FDA Product Code
- OOU FDA UDIOEM FDA UDIOZZ FDA UDIOCC FDA UDIOZE FDA UDIOEP FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 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-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Respiratory Pathogens Flex (RP Flex) Extraction Tray by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT).
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- Alinity m — Abbott Molecular · N
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- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
- Alinity m — Abbott Molecular · 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 cf6159c9-38e0-4911-91c2-1cffcf7d883f 37 fields · synced Jun 9, 2026