Home › Device types › JXN
Enzyme Immunoassay, Propoxyphene
FDA product code JXN · Class 2 · Clinical Toxicology
873
Registered devices
1
Adverse events
2
Recalls
22
510(k) clearances
Devices with this code
INCUP — AMERICAN BIO MEDICA CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONRTCII 1st gen. — AMERICAN BIO MEDICA CORPORATIONAlinity — ABBOTT LABORATORIESDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.iCup® — Instant Technologies, Inc.iCup® — Instant Technologies, Inc.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.Easy@Home Multi-Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATIONPropoxyphene Enzyme Immunoassay — LIN-ZHI INTERNATIONAL, INC.RTCII 1st gen. — AMERICAN BIO MEDICA CORPORATIONEasy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONNOBLE — NOBLE MEDICAL INCRapid TOX — AMERICAN BIO MEDICA CORPORATIONHealgen — Healgen Scientific Limited Liability CompanyCRL STAT Cup — CLINICAL REFERENCE LABORATORY, INC.INCUP — AMERICAN BIO MEDICA CORPORATIONSTATCUP® — MICRO DISTRIBUTING, L.CHealgen — Healgen Scientific Limited Liability CompanyDrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — Express Diagnostic Int'l, Inc.AlereTM iScreen® — Instant Technologies, Inc.SAFECUP III 13 PANEL — GERMAINE LABORATORIES, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-10-04 | Express Diagnostics Int'l., Inc. | Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labele |
| 2008-05-28 | Sun Biomedical Laboratories, Inc. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
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