← Product Code [QWB](/productcode/QWB) · K253453

# Metrix COVID Test; Metrix COVID Test Pro (K253453)

_Aptitude Medical Systems, Inc. · QWB · Aug 7, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253453

## Device Facts

- **Applicant:** Aptitude Medical Systems, Inc.
- **Product Code:** [QWB](/productcode/QWB.md)
- **Decision Date:** Aug 7, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3984
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

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.

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**Source:** [https://fda.innolitics.com/device/K253453](https://fda.innolitics.com/device/K253453)

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