ONE STEP Opiate (OPI/Morphine) Test

Trade name

ONE STEP Opiate (OPI/Morphine) Test

06936155806997

B-06936155806997

Reference / catalog number

ITP06002-TC40

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 Opiate (OPI/Morphine) Test is a rapid, qualitative assay for the determination of morphine and its metabolites in human urine. The test is used to screen urine for the presence of morphine and its metabolites at a cutoff concentration of 300 ng/mL. The test is for use by healthcare professionals only. This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Opiates include heroin, morphine and codeine, and opiate/heroin metabolites are rapidly converted to morphine and excreted in urine. The test is a qualitative visual screening immunoassay based on a competitive binding principle. Morphine or its metabolites in the urine compete with drug conjugate immobilized on the membrane for limited antibody binding sites. A negative specimen produces two colored bands, while a positive specimen produces only one control band. The control band indicates that sufficient sample volume has been added and that the reagents are functioning properly.

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.

• W0102160508OPIATES - RT & POC

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

• CW011

  For professional in vitro diagnostic use only. This product is designed for detection of morphine in human urine only and provides a preliminary qualitative screening result only. Positive results should be confirmed using an alternate method, preferably GC/MS, and clinical considerations and professional judgment should be applied. The test does not indicate the level of intoxication or monitor drug levels. Avoid cross-contamination of urine samples by using a new urine specimen cup for each sample, and do not interpret results after 8 minutes.
• CW010

  Read and follow the package insert carefully before use.
• CW032

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