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Dynamiker SARS-CoV-2 Neutralization Antibody Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref DNK-2101-1Model 20 tests
Identity
- Device Name
- Dynamiker SARS-CoV-2 Neutralization Antibody Rapid Test EUDAMED
- Model / Reference
- 20 tests EUDAMEDDNK-2101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317801363 EUDAMED
- Basic UDI-DI
- B-06930317801363 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria 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
The Dynamiker SARS-CoV-2 Neutralization Antibody Rapid Test is a highly sensitive and specific diagnostic tool designed to detect the presence of SARS-CoV-2 antibodies in individuals. This rapid test allows for quick and accurate results, making it an ideal solution for point-of-care testing.
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-06930317801363 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED cd204722-c203-445e-a52f-82949143f553 61 fields · synced Jul 12, 2026