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ARK™ Pregabalin II Assay

ARK DIAGNOSTICS INC · Model 5059-0001-00 · UDI-DI 00812101030448

NWM Prescription
5
510(k) clearances
2
Adverse events
0
Recalls
2
Facilities

Description

The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.