Singclean®

Trade name

Singclean®

06936020140423

69360201528X

Reference / catalog number

M90-02-25t

GS1

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Multi-Drug One Step Test Kit (Colloidal Gold Method) (BZO/BAR/MDMA/MTD/OXY)is a rapid chromatographic immunoassay for the qualitative detection for the drugs and drug metabolites in human urine. It is mainly used for aiding to diagnosis the drug dependence and drug withdrawal, and it's not for monitoring purpose.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102090199DRUGS OF ABUSE - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW010

   For in vitro diagnostic use only.  For professional laboratory use, and the users should have relevant qualifications.  Do not use after the expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.  After use, put all components back into their original aluminum foil bags or packaging bags, and dispose of the discarded packaging according to local regulations  All specimens should be considered potentially hazardous and handle in the same way as an infectious material.  Avoid cross-contamination of specimens by using a new specimen collection container and specimen pipette for each specimen obtained.  Read the entire procedure carefully prior to performing any tests.  The used testing materials should be discarded in accordance with local, state and/or federal regulations.  Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State.