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TaqPath™ COVID 19, Flu A, Flu B, RSV Select Negative Control

EUDAMED

Class B (EU MDR)

Ref 963610 (A56125)

by Life Technologies Corporation; Thermo Fisher Life Sciences

Identity

Trade Name
TaqPath™ COVID 19, Flu A, Flu B, RSV Select Negative Control EUDAMED
Device Name
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel EUDAMED
Model / Reference
963610 (A56125) EUDAMED

Identifiers

Primary DI / UDI-DI
10190302019088 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™ COVID 19, Flu A, Flu B, RSV Select Negative Control 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

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Manufacturer

EUDAMED SRN
US-MF-000026189
Authorised Representative
Life Technologies Europe B.V. NL-AR-000021890

Sources (1)

  • EUDAMED 232f82e0-9e82-4b93-8f80-efbed5173bb6 61 fields · synced Oct 6, 2026