QWBClass II

Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens

Microbiology · 21 CFR 866.3984

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.

MDR events1All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances3All time

Recent MDR events

1 adverse event reports on file

CUE CARTRIDGE READER C0201Jun 14, 2024
MalfunctionCue Health Inc.MW5156290

Event type breakdown

Malfunction1

Most-reported manufacturers

Cue Health Inc.1

Recalls

1 recall events for this product code

CUE HEALTH INC
Open, ClassifiedOct 15, 2024
Cue Health COVID-19 Test Cartridge REF 2900005
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Z-0091-2025 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

Siro Diagnostics, Inc.
San Diego, CA, US

510(k) clearances

3 clearances for this product code