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cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 09731261190 FDA UDI
Identifiers
- Catalog Number
- 09731261190 FDA UDI
- Primary DI / UDI-DI
- 00875197007299 FDA UDI
- 510(k) Number
- K243406 FDA UDI
- FDA Product Code
- QOF 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
- 866.3981 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Respiratory Pathogens Flex (RP Flex) Extraction Tray — Luminex Corporation · Class II
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Lyra — DIAGNOSTIC HYBRIDS, INC. · Class II
- BD Respiratory Viral Panel for BD MAX™ System — BECTON DICKINSON AND COMPANY · Class II
- Simplexa COVID-19 & Flu A/B Direct — DiaSorin Molecular LLC · Class II
- Alinity m — Abbott Molecular · N
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
Cleared under the same submission
K243406 also covers:
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
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI fe6258c6-ded5-4050-82e4-e2698f84de75 34 fields · synced Jun 9, 2026