Identity
- Trade Name
- TaqPath™ 1-Step Select Master Mix (No ROX) FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel) FDA UDI
- Model / Reference
- A56518 FDA UDI
- Description
- Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel) FDA UDI
Identifiers
- Catalog Number
- A56123 FDA UDI
- Primary DI / UDI-DI
- 10190302019019 FDA UDI
- 510(k) Number
- K241806 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
No
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)
TaqPath™ 1-Step Select Master Mix (No ROX) by Life Technologies Limited — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- 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
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
- Alinity m — Abbott Molecular · Class II
- Panther Fusion® — Hologic, Inc. · Class I
Cleared under the same submission
K241806 also covers:
- TaqPath™ 1-Step Select Master Mix (No ROX) — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control — LIFE TECHNOLOGIES LIMITED
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control — LIFE TECHNOLOGIES LIMITED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Limited
Sources (2)
- FDA UDI a33e2578-2274-46cd-b77c-c7736746161e 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026