PVQClass II

Rickettsia Spp. Nucleic Acid Based Detection Assay

21 CFR 866.3316 / Microbiology

PVQ is the FDA product code for Rickettsia Spp. Nucleic Acid Based Detection Assay, a class II device type, regulated under 21 CFR 866.3316. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2017-06-29, and no recalls.

Classification record

Product code: PVQ
Device name: Rickettsia Spp. Nucleic Acid Based Detection Assay
FDA 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.
Regulation: 21 CFR 866.3316
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code PVQ

By decision year

1 clearance under product code PVQ with a decision year between 2017 and 2017, 2017 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PVQ by decision year
Year	Clearances
2017	1

Applicants with the most clearances

Product code PVQ

Applicants holding the most 510(k) clearances under product code PVQ
Applicant	Clearances
Centers for Disease Control and Prevention (CDC)	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PVQ.

Recent clearances

Product code PVQ

K170940Class IIRickettsia Real-time PCR AssayCenters For Disease Control and Prevention (CDC) / cleared 2017-06-29

Recent recalls

Product code PVQ

FDA records show no recalls under product code PVQ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)