Sars-Cov-2 Serology Test

QVP · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3983

Classification

FDA Product Code: QVP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3983
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 8

Source

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