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ARK™ Lamotrigine Assay

ARK DIAGNOSTICS INC · Model 5023-0001-00 · UDI-DI 00858724003025

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

Description

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