OVF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Assay, Direct, Nucleic Acid Amplification, Q Fever

Device class

Class I (low risk)

Regulation

21 CFR 866.3500

Medical specialty

Microbiology

FDA definition

These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.

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