First HIV diagnostic assay approved

admin — Tue, 20 Oct 2009 07:26:29 +0000

Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

VITROS(R) 3600 Immunodiagnostic System Receives 510(k) Clearance From The FDA

admin — Fri, 02 Jan 2009 08:46:02 +0000

Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October.

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First HIV diagnostic assay approved

VITROS(R) 3600 Immunodiagnostic System Receives 510(k) Clearance From The FDA