Zika Virus Serological Reagents

QFO · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3935

Classification

FDA Product Code: QFO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3935
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 8

Source

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