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Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112236

by Guangzhou Wondfo Biotech Co., Ltd.

Identifiers

510(k) Number
K112236 FDA 510(k)
FDA Product Code
LAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3610 FDA 510(k)
Regulation Number
862.3610 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a lateral flow chromatographic immunoassay for the qualitative detection of methylenedioxymethamphetamine and morphine in human urine. It operates via competitive binding immunoassay, where the urine sample migrates by capillary action through a nitrocellulose membrane containing a test line coated with drug antigen-protein conjugates.

The test is available in formats such as dip cards or integrated urine cups. It is intended for use in clinical toxicology settings and is supplied as a single-use in vitro diagnostic device. The device received FDA 510(k) clearance under K112236, product code LAF, and is classified as a Class II device under regulation 862.3610 with a medical specialty in Clinical Toxicology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine ..., fda.innolitics.com, Methylenedioxymethamphetamine Urine Test,Morphine Urine Test

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K112236 24 fields · synced Oct 6, 2026