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ARK™ Zonisamide Assay

ARK DIAGNOSTICS INC · Model 5022-0001-00 · UDI-DI 00858724003018

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

Description

The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme.

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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.