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510(k) Data Aggregation
K Number
K102428Device Name
WUNDER TEST
Manufacturer
Date Cleared
2012-04-18
(601 days)
Product Code
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
HIEN HELEN NGUYEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Device Description
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