THC Test Kit(Urine)

Trade name

THC Test Kit(Urine)

UDI-DI code

86979834610009

Basic UDI-DI

B-86979834610009

Reference / catalog number

THC0065

Issuing entity

GS1

Risk category

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 THC test kit is a rapid chromatographic immunoassay for the detection of 11-nor-9-THC-9- COOH(THC metabolite) in human urine at a cut-off concentration of 50ng/mL. This assay 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 spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

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

• CW218

  EUDAMED did not publish a description for this code.
• CW463

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• CW018

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• CW278

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• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW022

  EUDAMED did not publish a description for this code.
• CW020

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.