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Noble 1 Step + Cup

NOBLE MEDICAL INC · Model NBCA-13A-B · UDI-DI 00858886006285

LFGDJRDISJXMDKZDJCDJGDIOLDJ Prescription
1
510(k) clearances
8
Adverse events
2
Recalls
49
Facilities

Description

Drugs of Abuse Test Cup for THC50/COC150; OPI300/MET500; AMP500/BZ0300; BZO300/MT300; MDMA500/OXY100; BUPG10/TCA1000; with Cr, Ni, pH, Bl, S.G.

Recalls

DateFirmReason
2026-06-26Siemens Healthcare Diagnostics, Inc.out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h
2003-11-17Abbott Health Products, Inc.Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.