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ARK™ Levetiracetam Assay

ARK DIAGNOSTICS INC · Model 5024-0001-00 · UDI-DI 00858724003032

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

Description

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