DeviceClearance

Product code OVF— Microbiology

JBAIDS Q FEVER DETECTION KIT

Classification name
Assay, Direct, Nucleic Acid Amplification, Q Fever
Device class
Class 1
Regulation
21 CFR 866.3500
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OVF under 21 CFR 866.3500, via openFDA

Market context for product code OVF

FDA has cleared 1 device under product code OVF, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OVF

Recent clearances under product code OVF

Data sourced from openFDA. This site is unofficial and independent of the FDA.