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Logix Smart ABC (Influenza A +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref ABC-K-001
Identity
- Trade Name
- Logix Smart ABC (Influenza A/B, SARS-Cov-2) EUDAMED
- Device Name
- Logix Smart ABC (Influenza A/B, SARS-CoV-2) EUDAMED
- Model / Reference
- ABC-K-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ABC-K-001H5 EUDAMED
- Basic UDI-DI
- B-ABC-K-001H5 EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS EUDAMED
- Models / Variants
- Influenza A EUDAMEDB EUDAMEDSARS-Cov-2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Logix Smart ABC (Influenza A +2 more) by Co-Diagnostics, Inc. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-ABC-K-001H5 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Co-Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000036425
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 923371d8-b69e-41a0-a517-83eee5cb6445 61 fields · synced Jun 19, 2026