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Accu-Tell® COVID-19 Antigen Cassette (Saliva)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-IDT-B372Model CassetteRef ABT-IDT-B384
Identity
- Trade Name
- Accu-Tell® COVID-19 Antigen Cassette (Saliva) EUDAMEDAccu-Tell® COVID-19 Antigen Cassette (Saliva/ Nasopharyngeal Swab) EUDAMED
- Device Name
- Accu-Tell® COVID-19 Antigen Cassette EUDAMED
- Model / Reference
- Cassette EUDAMEDABT-IDT-B372 EUDAMEDABT-IDT-B384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970581432320 EUDAMEDD-ABT-IDT-B384VS EUDAMED
- Basic UDI-DI
- B-06970581432320 EUDAMEDB-ABT-IDT-B384VS 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 (Saliva) by AccuBioTech Co., Ltd. — 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-06970581432320 | 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 811e7981-79b7-4fec-92d9-ab828130e5af 61 fields · synced Oct 6, 2026
- EUDAMED 19794a7b-ae20-47a3-b897-208177737052 61 fields · synced May 19, 2026