Rickettsia Spp. Nucleic Acid Based Detection Assay

PVQ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3316

Classification

FDA Product Code: PVQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3316
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown