Modif. of Emit Cad Disopyramide Assay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K833623 ↗

FDA Product Code

KLR

Device Class

Class II

Regulation

21 CFR Part 862.3555

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Syva Co. →

• What is the MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY used for?

  This device is an enzyme immunoassay designed for the detection of disopyramide in clinical specimens, intended for use in clinical toxicology settings as an in vitro diagnostic reagent system.

• How is the MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY supplied and what is its format?

  The assay is supplied as a reagent system for in vitro diagnostic use, meaning it includes the necessary components to perform the enzyme immunoassay test for disopyramide detection in a laboratory setting.

• Is the MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY intended for single-use or reuse?

  As an in vitro diagnostic reagent system, the assay is designed for single-use per test run, with reagents consumed during the enzyme immunoassay process to detect disopyramide in clinical specimens.