ONE STEP Tramadol (TRA) Test

Trade name

ONE STEP Tramadol (TRA) Test

06936155803613

B-06936155803613

Reference / catalog number

ITP06014-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 Tramadol (TRA) Test is a rapid, qualitative assay for determination of tramadol and its metabolites in human urine. The test is used to screen urine for presence of tramadol and its metabolites. The test is for use by healthcare professionals only and provides only a preliminary analytical result; positive results should be confirmed using a more specific method such as GC/MS. Tramadol is a quasi-narcotic analgesic used in the treatment of moderate to severe pain and is extensively metabolized after oral administration. The test is a monoclonal antibody-based competitive immunoassay. Tramadol or its metabolites in 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 the reagents and device are functioning correctly.

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.

• W0102160599DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER

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

• CW011

  For professional in vitro diagnostic use only. This product is intended for screening of the specified drug(s) and/or metabolites in human urine only, provides only a preliminary qualitative analytical result, and positive results should be confirmed using a more specific alternate method, preferably GC/MS. Clinical consideration and professional judgment should be applied, particularly when preliminary results are positive. 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
• CW008

  Handle and dispose of residual urine and all used devices in an approved biohazard container
• CW032

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