THC Test Kit(Urine)
by Neo-nostics (Suzhou) Bioengineering Co., Ltd. China EUDAMED
Ref THC0065Model Rapid qualitative detection of cotinine in human urine by competitive inhibition colloidal gold immunochromatography. Cotinine, with longer half-life, serves as marker for smoking/cessation. Suitable for preliminary screening of tobacco smoke intake. EMDN W0102160599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-86979834610009 | Date19 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- Rapid qualitative detection of cotinine in human urine by competitive inhibition colloidal gold immunochromatography. Cotinine, with longer half-life, serves as marker for smoking/cessation. Suitable for preliminary screening of tobacco smoke intake., THC0065
- Primary DI / UDI-DI
- 86979834610009
- Basic UDI-DI
- B-86979834610009
- EMDN Code
- W0102160599 Drugs of abuse/toxicology rt & poc - other
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000013087
- Authorised representative
- Medunion S.L. ES-AR-000019366
Other devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 86223ec2-ba9d-4ebb-acaa-0c4318d4d7eb