FDA Device Intelligence
HomeARK DIAGNOSTICS INC › ARK™ Levetiracetam Control

ARK™ Levetiracetam Control

ARK DIAGNOSTICS INC · Model 5024-0003-00 · UDI-DI 00858724003155

LAS Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
24
Facilities

Description

The ARK™ Levetiracetam Control is intended for use in quality control of the ARK™Levetiracetam Assay.

Recalls

DateFirmReason
2013-10-03Lin-Zhi International IncProduct catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.