News and Events

October 2011

ARK Diagnostics received 510(k) clearance from FDA for the ARK Methotrexate Assay.

October 2011

IATDMCT

October 2-6 2011, Stuttgart, Germany

July 2011

AACC

July 26-28 2011, Atlanta, GA

April 2011

Attended AACC-TDM Division Meeting

Chicago, IL

December 2010

ARK Immunoassays for Antiepileptic Drugs: Gabapentin, Lamotrigine, Levetiracetam, Topiramate, Zonisamide

American Epilepsy Society, 64th Annual Meeting

December 3-7, San Antonio, TX

November 2010

ARK Diagnostics received 510(k) clearance from FDA for the ARK Gabapentin Assay.

October 2010

ARK achieved re-certification to ISO13485:2003 (FM523575)

ARK Diagnostics received 510(k) clearance from FDA for the ARK Lamotrigine Assay.

July 2010

2010 AACC and ASCLS Annual Meetings and Clinical Lab Expo

ARK Immunoassay for Gabapentin
ARK Immunoassay for Lamotrigine
Application Of Levetiracetam (Keppra) Monitoring To Standard Laboratory Analyzers
ARK Topiramate Assay on The Ortho-Clinical Diagnostics Vitros® 5,1 FS Chemistry System
July 25-29, 2010

July 2010

ARK Diagnostics Announces Commercialization of AED Assays in Europe

ARK Diagnostics Provides New TDM Tools for Personalized Medicine

December 2009

ARK Diagnostics received 510(k) clearance from FDA for the ARK Zonisamide Assay.

November 2009

ARK Diagnostics received 510(k) clearance from FDA for the ARK Levetiracetam Assay.

October 2009

11th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology

ARK Homogeneous Enzyme Immunoassays for the Newer Antiepileptic Drugs
October 3-8, Montréal

July 2009

ARK introduces three assays at the 2009 Annual Meeting of the American Association of Clinical Chemistry. ARK Topiramate Assay is FDA cleared. FDA clearance is pending for ARK Levetiracetam Assay and ARK Zonisamide Assay.

2009 AACC (American Association for Clinical Chemistry) Annual Meeting
July 18 - 23, Chicago

July 2009

2009 AACC (American Association for Clinical Chemistry) Annual Meeting
July 18 - 23, Chicago

ARK Topiramate Assay on Roche/Hitachi 917 System

Validation of New Immunoassay for Quantification of Topiramate

April 2009

ARK Diagnostics received 510(k) clearance from FDA for the ARK Topiramate Assay.

July 2008

2008 AACC (American Association for Clinical Chemistry) Annual Meeting
July 27 - 31, Washington, DC

Therapeutic Drug Monitoring Immunoassay for Efavirenz

November 2007

ARK achieved ISO 13485:2003 certification (certificate number FM 523575). ARK is committed to providing quality products to its customers and this certification is evidence of ARK's commitment and its established quality management system.

June 2007

ARK achieved a Device Manufacturing License from the State of California.

April 16-18, 2007

8th International Workshop on Clinical Pharmacology of HIV Therapy
Budapest, Hungary

The ARK APV-Test™:Rapid Automated Immunoassay for Amprenavir in Human Plasma

September 27, 2006

46th Interscience Conference on Antimicrobial Agents and Chemotherapy
San Francisco, California

Rapid Automated Immunoassay for Therapeutic Drug Monitoring of Lopinavir: Method Evaluation and Comparison to LC-MS-MS

August 2006

XVI International AIDS Conference
Toronto, Canada

The ARK EFV-Test™: A Rapid, Automated Immunoassay for Therapeutic Drug Monitoring of Efavirenz

July 16, 2006

ARK Diagnostics, Inc. joined 20th Annual AIDS Walk San Francisco.

View certificate

April 20-22, 2006

7th International Workshop on Clinical Pharmacology of HIV Therapy
Lisbon, Portugal

Novel Atazanavir Immunoassay

Rapid, Automated Immunoassay for Atazanavir in Plasma and Cerebrospinal Fluid (CSF) Using the ARK ATV-Test™ : Methods Validation, Application and Comparison with HPLC Plasma Method