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FDA 510(k)

FINDER Flu A&B/SARS-CoV-2 Test

K-Number: K252269 · 2026-03-30

ApplicantBaebies, Inc.
Decision Date2026-03-30
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FINDER Flu A&B/SARS-CoV-2 Test is the device name listed in this FDA 510(k) record. The listed applicant is Baebies, Inc.. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K252269. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINDER Flu A&B/SARS-CoV-2 Test?

FINDER Flu A&B/SARS-CoV-2 Test is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Baebies, Inc.. The 510(k) number is K252269.

When did FINDER Flu A&B/SARS-CoV-2 Test receive FDA 510(k) clearance?

FINDER Flu A&B/SARS-CoV-2 Test received FDA 510(k) clearance on 2026-03-30, under 510(k) number K252269.

Who is the listed applicant for FINDER Flu A&B/SARS-CoV-2 Test?

The FDA 510(k) record lists Baebies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINDER Flu A&B/SARS-CoV-2 Test?

The FDA product code for FINDER Flu A&B/SARS-CoV-2 Test is QOF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Baebies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201049FINDER G6PD

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbHK243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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