OVF

Assay, Direct, Nucleic Acid Amplification, Q Fever

Product code

OVF

Device name

Assay, Direct, Nucleic Acid Amplification, Q Fever

Device class

Class 1

21 CFR

21 CFR 866.3500

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).