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ARK™ Gabapentin Assay (c-pack)

ARK DIAGNOSTICS INC · Model 5025-0001-01 · UDI-DI 00858724003261

OTF Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
2
Facilities

Description

The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

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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.