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HIV-1 Genotyping Kit
EUDAMEDClass IVD General (EU MDR)
Ref A54401
by Life Technologies Corporation; Thermo Fisher Life Sciences
Identity
- Trade Name
- HIV-1 Genotyping Kit EUDAMED
- Device Name
- Applied Biosystems™ TaqPath™ Seq HIV-1 Genotyping Kit EUDAMED
- Model / Reference
- A54401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302018128 EUDAMED
- Basic UDI-DI
- B-10190302018128 EUDAMED
- EMDN Code
- W0105030108 HIV 1 GENOTYPING - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
HIV-1 Genotyping Kit by Life Technologies Corporation; Thermo Fisher Life Sciences — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-10190302018128 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000026189
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED 87ec45ee-b486-4801-ad8a-a6cfb012f2c9 61 fields · synced Jun 19, 2026