510(k) cleared for OTC use Drug substance Abuse test dipcard For AMP BUP COC OPI BZO

Rapid Single/Multi-drug Test Dipcard is a rapid, screening test for the qualitative detection of single/multiple drugs and drug metabolites in human urine at specified cut off levels.

For in vitro diagnostic use only.

INTENDED USE

Rapid Single/Multi-drug Test Cup is an immuno-chromatographic assay for the qualitative determination of the presence of drugs listed in the table below.

Amphetamine (AMP)   1000ng/mL

Buprenorphine (BUP)     10ng/ml

Cocaine (COC)              300ng/ml

Morphine 2000 (OPI)       2000ng/ml

Benzodiazepines (BZO)     300ng/ml

HOW TO PERFORM THE TEST?

Test must be in room temperature (15ºC to 30ºC)

1. Open the sealed pouch by tearing along the notch. Remove the test dipcard from the pouch.

2. Immerse the dipcard into the urine with the arrow pointing towards the urine. Take the dipcard out after 10 seconds.

IMPORTANT: Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.

3. Lay the test dipcard on a clean, dry, non-absorbent surface.

4. Read the results at 5 minutes. The drug test results remain stable for up to thirty minutes.

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