Alltest Fentanyl Rapid Test (Urine)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231698 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alltest Fentanyl Rapid Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of Fentanyl in Urine. It utilizes a monoclonal antibody to selectively detect elevated levels of Fentanyl in specimen.
The test is supplied for use in clinical settings and is regulated under product code DJG and regulation number 862.3650. It has been cleared by the FDA under the traditional clearance type with decision code SESE. The device is intended for single use and is not specified as sterile or non-sterile in the provided data.
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 - en.alltests.com.cn, HANGZHOU ALLTEST BIOTECH CO.,LTD - en.alltests.com.cn, AllTest Fentanyl Rapid Test (Urine) (K231698) — FDA 510(k) | Innolitics, PDF Hangzhou AllTest Biotech Co., Ltd. ℅ Joe Shia Director LSI ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231698 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou AllTest Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K231698 24 fields · synced Sep 22, 2026