PRA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3316
Classification
FDA Product Code
PRA
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
The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.