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Noble 1 Step + Cup
NOBLE MEDICAL INC · Model NBCA-13A-B · UDI-DI 00858886006285
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
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens 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 |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.
