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Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-IDT-B378Model CassetteRef ABT-IDT-B374
Identity
- Trade Name
- Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab) EUDAMEDAccu-Tell® COVID-19 Antigen Cassette (Nasal Swab) EUDAMED
- Device Name
- Accu-Tell® COVID-19 Antigen Cassette EUDAMED
- Model / Reference
- Cassette EUDAMEDABT-IDT-B378 EUDAMEDABT-IDT-B374 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ABT-IDT-B378VX EUDAMED06970581432337 EUDAMED
- Basic UDI-DI
- B-ABT-IDT-B378VX EUDAMEDB-06970581432337 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab) by AccuBioTech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-ABT-IDT-B378VX | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AccuBioTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025172
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 19a528fa-7456-425f-bf5d-4ec3747c4422 61 fields · synced Oct 6, 2026
- EUDAMED 6479d80f-2949-4aaf-85be-afeede50043e 61 fields · synced May 18, 2026