ONE STEP Multi-12 DOA Test

Trade name

ONE STEP Multi-12 DOA Test

06936155807116

B-06936155807116

Reference / catalog number

ITP06111-DT10

GS1

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The One Step Multi-12 DOA Test is a rapid, qualitative, competitive immunoassay for the determination of Drug-of-Abuse (DOA) and/or their metabolites in human urine. The device allows the detection of multiple drugs in one simple step. The One Step Multi-12 DOA Test is intended to be used in Professional Medical & Forensic laboratories. This test provides only preliminary data which should be confirmed by other methods such as gas chromatography / mass spectrophotometry (GC/MS). This test is not intended to monitor drug levels, but only to screen urine for the presence of the drugs mentioned and their metabolites. The test is used for screening common drugs of abuse and/or their metabolites in urine, including analytes such as amphetamines, cocaine/benzoylecgonine, opiates/morphine, THC/cannabinoids, methamphetamine, benzodiazepines, barbiturates, phencyclidine, MDMA, ketamine, TCA, methadone, buprenorphine and tramadol, depending on the test configuration. The One Step Multi-12 DOA Test is based on a competitive immunoassay principle and consists of 12 chromatographic strip(s), as per the format, for individual drugs of abuse. Urine initially reacts with antibody-colloidal gold conjugate and migrates by capillary action to the test area. If sufficient drug is present, it prevents the conjugate from binding to the drug conjugate immobilized on the membrane in the test region, so a positive specimen produces only the control line. A negative specimen produces both test and control lines. The control line indicates that the result is valid.

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.

• W0102160511MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC

4 warnings recorded — scroll inside the panel to see all entries.

• CW011

  For professional Medical and Forensic use only and for in vitro diagnostic use only. This test provides preliminary screening results only and is not intended to monitor drug levels or determine quantitative drug levels. Positive results should be confirmed by GC/MS or another appropriate method. Avoid cross-contamination by using a new urine sample cup for each sample and do not interpret results after 8 minutes.
• CW010

  Read and follow the package insert carefully before use.
• CW008

  Properly handle and dispose of residual urine and all used reaction devices in an approved biohazard container
• CW032

  Do not use the kit beyond the expiration date imprinted on the outside of the foil pouch.