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Identify Diagnostics Multi-Drug Rapid Test Cup

Model ID-AT10-1-AZ25 · Hangzhou AllTest Biotech Co., Ltd. · DI 16942598206345

NFT — Test, Amphetamine, Over The Counter · Class II · 21 CFR 862.3100

NFV — Test, Benzodiazepine, Over The Counter · Class II · 21 CFR 862.3170

NFY — Test, Cocaine And Cocaine Metabolites, Over The Counter · Class II · 21 CFR 862.3250

NGG — Test, Methamphetamine, Over The Counter · Class II · 21 CFR 862.3610

NGL — Test, Opiates, Over The Counter · Class II · 21 CFR 862.3650

PTG — Test, Methadone, Over The Counter · Class II · 21 CFR 862.3620

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2026-05	0	2
2026-06	0	2

This device (reports/month)Average device in NFT, NFV, NFY, NGG, NGL, PTG (reports/device/month)

Regulatory clearances

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Manufacturer compliance record — Hangzhou AllTest Biotech Co., Ltd.

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