Prime Screen
Model DTDOA-274-25BX-A · WONDFO USA CO., LTD. · DI 00816862024913
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
UDILibrary device dossier · generated 2026-09-13 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K182701 — cites (transitively): K122809 (d1) — cited as predicate by K191841, K202567, K210327, K220685, K222667, K242077, K252550
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — WONDFO USA CO., LTD.
- VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations
- VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations