Identity
- Trade Name
- LIAISON PLEX® Respiratory Flex Assay Kit FDA UDI
- Generic Name
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2. FDA UDI
- Model / Reference
- 20-005-322 FDA UDI
- Description
- The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2. FDA UDI
Identifiers
- Catalog Number
- 20-005-322 FDA UDI
- Primary DI / UDI-DI
- 00840487101940 FDA UDI
- 510(k) Number
- K233410 FDA UDI
- FDA Product Code
- QOF FDA UDI
- GMDN Term
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3981 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
Yes
FDA UDI
Category: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
LIAISON PLEX® Respiratory Flex Assay Kit by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0703a478-e2cf-4b99-86ab-aec6273aae34 37 fields · synced Jun 9, 2026