← Back to catalogue
QuicAbTM Talaromyces marneffei Ab Lateral Flow Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-17Model 50 tests
Identity
- Device Name
- QuicAbTM Talaromyces marneffei Ab Lateral Flow Assay EUDAMED
- Model / Reference
- 50 tests EUDAMEDDNK-1901-17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317802025 EUDAMED
- Basic UDI-DI
- B-06930317802025 EUDAMED
- EMDN Code
- W0105060399 MYCOLOGY IMMUNOASSAYS - OTHER 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
Yes
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
QuicAbTM Talaromyces marneffei Ab Lateral Flow Assay by Dynamiker Biotechnology (Tianjin) 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-06930317802025 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0217da36-fcb2-43bf-9fd2-bd47cdf02316 61 fields · synced Jul 16, 2026