Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

QWB · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3984

Classification

FDA Product Code: QWB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3984
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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