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TaqPath™ 1-Step Select Master Mix (No ROX)
EUDAMEDClass B (EU MDR)
Ref A56520 (A56125)
by Life Technologies Corporation; Thermo Fisher Life Sciences
Identity
- Trade Name
- TaqPath™ 1-Step Select Master Mix (No ROX) EUDAMED
- Device Name
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel EUDAMED
- Model / Reference
- A56520 (A56125) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302019095 EUDAMED
- Basic UDI-DI
- 0190302A56125SA EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
TaqPath™ 1-Step Select Master Mix (No ROX) by Life Technologies Corporation; Thermo Fisher Life Sciences — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302A56125SA | Class B | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000026189
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED 20b8c7c3-336c-4520-bdce-a7e435e2d847 61 fields · synced Jul 8, 2026