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AllTest Multi-Drug Urine Test Cup

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241428

by Hangzhou AllTest Biotech Co., Ltd.

Identifiers

510(k) Number
K241428 FDA 510(k)
FDA Product Code
NFT FDA 510(k)
Models / Variants
AllTest Multi-Drug Urine Test Cup FDA 510(k)
AllTest Multi-Drug Rapid Urine Test Cup 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 AllTest Multi-Drug Urine Test Cup is a rapid screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine specimen. It utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs and is designed to be performed without the use of an instrument.

The device is supplied as a test cup for use in healthcare settings and is intended for over-the-counter use. It has received FDA 510(k) clearance (K241428) and is classified as a Class II device under regulation number 862.3100, with product code NFT and advisory committee review in Clinical Toxicology (TX).

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: HANGZHOU ALLTEST BIOTECH CO.,LTD - alltests.com.cn, HANGZHOU ALLTEST BIOTECH CO.,LTD - alltests.com.cn, AllTest Drug Testing Supplies for CLIA Waived Screening

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou AllTest Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K241428 24 fields · synced Oct 6, 2026