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AllSource

Model ALL8145 · Guangzhou Decheng Biotechnology Co., LTD · DI 00850065976051

DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650

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

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

NFW — Test, Cannabinoid, Over The Counter · Class II · 21 CFR 862.3870

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

NGM — Test, Phencyclidine (Pcp), Over The Counter

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

PTH — Test, Barbiturate, Over The Counter · Class II · 21 CFR 862.3150

QAW — Test, Tricyclic Antidepressants, Over The Counter · Class II · 21 CFR 862.3910

QBF — Test, Propoxyphene, Over The Counter · Class II · 21 CFR 862.3700

UDILibrary device dossier · generated 2026-09-07 · 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)
2019-01	0	1
2019-02	0	1
2019-05	0	1
2019-06	0	1
2019-07	0	1
2019-10	0	2
2021-07	0	1
2022-06	0	1
2026-04	0	1
2026-05	0	2
2026-06	0	2

This device (reports/month)Average device in DJG, NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K232659 — cites (transitively): K201630 (d1), K181768 (d2), K182123 (d2), K122809 (d3) — cited as predicate by K240686, K240698, K250067

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Guangzhou Decheng Biotechnology Co., LTD

Nothing in the loaded window.