← Back to catalogue

Wondfo T-Cup Multi-Drug Urine Test Cup

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182701

by Guangzhou Wondfo Biotech Co., Ltd.

Identifiers

510(k) Number
K182701 FDA 510(k)
FDA Product Code
NFT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wondfo T-Cup Multi-Drug Urine Test Cup is a lateral flow chromatographic immunoassay designed for the simultaneous detection of multiple drugs in urine specimens. It is a rapid, self-contained urinalysis device that absorbs urine into the test strip, allowing migration by capillary action for visual readout of results.

This device is intended for use in professional IVD labs and clinics, providing flexible 2-16/18 drug screening. It is supplied as a test cup and is authorized under FDA 510(k) clearance (K182701) with product code NFT and regulation number 862.3100, classified as a Class II medical device in the Clinical Toxicology specialty.

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: Multi-Drug Urine Test Panel, T-Cup & Q-Cup | Wondfo, Wondfo T-Cup Multi-Drug Urine Test Cup - Innolitics, Urinary disease test kit - T-cup® - Guangzhou Wondfo Biotech Co.,Ltd ..., Wondfo T-Cup® Multi-Drug Urine Test Cup, 5-Panel (CLIA Waived), 100/Case

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K182701 24 fields · synced Oct 6, 2026