PVQ

Rickettsia Spp. Nucleic Acid Based Detection Assay

Product code

PVQ

Device name

Rickettsia Spp. Nucleic Acid Based Detection Assay

Device class

Class 2

21 CFR

21 CFR 866.3316

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

An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.

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