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ARK™ Ethyl Glucuronide Assay

ARK DIAGNOSTICS INC · Model 5036-0004-00 · UDI-DI 00858724003605

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

Description

The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers.

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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.