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Agilent Registers Facility with FDA as Medical Device Establishment

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Agilent said today it has registered its 80,000 square-foot manufacturing facility in Cedar Creek, Texas, with the US Food and Drug Administration as a medical device establishment.

The registration is required for manufacturing diagnostic products, which the Santa Clara, Calif.-based firm said it intends to develop.

Agilent manufactures and packages a wide range of research bioreagents at the Cedar Creek facility, including enzyme-based reagents and high-fidelity oligonucleotides. It has also built separate, dedicated diagnostics space with a capability for expansion.

"Many of Agilent's proven research platforms hold potential in diagnostic markets," Robert Schueren, Agilent VP of Genomics, said in a statement. "We've made a commitment to bring improved diagnostic tools to the medical community. Having an FDA-registered manufacturing facility is yet another step in this endeavor."