Ark Diagnostics Inc

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Contact: Kenneth Kasper
Web: http://www.ark-tdm.com
E-Mail:
Address: 1190 Bordeaux Drive, Sunnyvale, California 94089, USA
Phone: +1-(408)-7470700 | Fax: +1-(408)-7470783 | Map/Directions >>

Profile: ARK Diagnostics Inc. manufactures vitro diagnostic products. We offer epilepsy and pain management and HIV/AIDS tests. Our ARK™ assays employ a homogeneous enzyme immunoassay technology based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase for binding to antibody reagent. Its active enzyme converts the coenzyme nicotinamide adenine dinucleotide to NADH that is measured spectrophotometrically as a rate of change in absorbance. Our TDM- HIV/AIDS maintains adequate drug concentrations in the bloodstream throughout the dosing interval. It guides dosing decisions and plays a critical role in the HIV health care continuum.

The company is ISO 13485:2003 certified.

FDA Registration Number: 3005755244

8 Products/Services (Click for related suppliers)

• Anti-Seizure Drug Immunoassay (FDA Code: NWM / 862.3350)

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

• Calibrators

• Diagnostic Products

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• Drug Specific Control Test (FDA Code: LAS / 862.3280)

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• Levetiracetam Assay (FDA Code: ORI / 862.3350)

• Pain Management System

• Topiramatee Test System (FDA Code: MSL)