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QuicGTM Fungus (1-3)-β-D-Glucan Lateral Flow Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-2301-1Model 20 tests/kitModel 1 test/bagModel 100 testsModel 40 tests
Identity
- Device Name
- QuicGTM Fungus (1-3)-β-D-Glucan Lateral Flow Assay EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDDNK-2301-1 EUDAMED1 test/bag EUDAMED100 tests EUDAMED40 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317801424 EUDAMED06930317801417 EUDAMED06930317801479 EUDAMED06930317801431 EUDAMED
- Basic UDI-DI
- B-06930317801424 EUDAMEDB-06930317801417 EUDAMEDB-06930317801479 EUDAMEDB-06930317801431 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - 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
QuicGTM Fungus (1-3)-β-D-Glucan 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-06930317801424 | 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 (4)
- EUDAMED 0cefc155-5bdc-4190-88b6-50e3413b1e0b 61 fields · synced Oct 6, 2026
- EUDAMED 5ba7655d-988c-4d68-b71d-0770973b8000 61 fields · synced May 17, 2026
- EUDAMED 9bbe9cb0-f959-4e05-bfd4-796b36055441 61 fields · synced May 17, 2026
- EUDAMED d958a99a-ec95-4899-9f6e-40e0a93d45d8 61 fields · synced May 19, 2026