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ARK™ Zonisamide Assay

The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme.

Details

Device typeZonisamide therapeutic drug monitoring IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the central nervous system drug zonisamide in a clinical specimen.

FDA categoryImmunoassay, Anti-Seizure Drug

Device ID00858724003018

Catalog number5022-0001-00

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone5102706270

Emailcustomersupport@ark-tdm.com

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