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Multi-Drug Rapid Test Panel
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref DOA-184Ref DOA-N154-012JRef DOA-N194-002BRef DOA-N184-002Ref DOA-N154-050JRef DOA-N194-003B510(k) K233019
Identity
- Trade Name
- Multi-Drug Rapid Test Panel EUDAMEDMulti- Drug Rapid Test EUDAMED
- Device Name
- Multi-Drug Rapid Test Panel EUDAMEDMulti- Drug Rapid Test EUDAMED
- Model / Reference
- DOA-184 EUDAMEDDOA-N154-012J EUDAMEDDOA-N194-002B EUDAMEDDOA-N184-002 EUDAMEDDOA-N154-050J EUDAMEDDOA-N194-003B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983188692 EUDAMED06936983160414 EUDAMED06936983159432 EUDAMED06936983142939 EUDAMED06936983160780 EUDAMED06936983159449 EUDAMED
- Basic UDI-DI
- B-06936983188692 EUDAMED6970277510007UZ8 EUDAMED6970277510012FXY EUDAMED6970277510011WYX EUDAMED6970277510009GYJ EUDAMED6970277510012GY2 EUDAMED
- 510(k) Number
- K233019 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
New Device
No
EUDAMED
Multi-Drug Rapid Test Panel by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — FDA_510K, IVDR, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233019 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDR | B-06936983188692 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06936983188692 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (7)
- EUDAMED 1815c070-497a-4efb-9d4e-75e5792ccba8 61 fields · synced Sep 18, 2026
- EUDAMED 19a99136-a9d8-4814-a3f4-ecaaf1b6f8e8 61 fields · synced May 11, 2026
- EUDAMED 531fc953-2f34-4f45-bc32-c7defea1a9d7 61 fields · synced May 17, 2026
- EUDAMED a16c83d6-5495-4db9-8de6-64f2eadcba50 61 fields · synced May 18, 2026
- EUDAMED e6de18e0-f6cc-419b-8d9a-9b9d6fea21d4 61 fields · synced May 18, 2026
- EUDAMED 9404d47a-22b3-4364-b345-934ede07fe19 61 fields · synced May 18, 2026
- FDA 510(k) K233019 24 fields · synced May 18, 2026