5 Panel Drug Test Cup
Model U-CUP-154 · UCP BIOSCIENCES, INC. · DI 10817038022280
DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Class II · 21 CFR 862.3250
DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650
DKZ — Enzyme Immunoassay, Amphetamine · Class II · 21 CFR 862.3100
LCM — Enzyme Immunoassay, Phencyclidine
LDJ — Enzyme Immunoassay, Cannabinoids · Class II · 21 CFR 862.3870
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) |
|---|---|---|
| 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 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 1 |
| 2026-06 | 0 | 3 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — UCP BIOSCIENCES, INC.
- VAI 2024-11-18 UCP Bioscience Inc · 3 citations
- NAI 2014-09-12 UCP Bioscience Inc · 0 citations