FINDER Flu A&B/SARS-CoV-2 Test— 510(k) K252269
Substantially EquivalentBaebies, Inc.
FDA 510(k) clearance K252269 for FINDER Flu A&B/SARS-CoV-2 Test, Substantially Equivalent on 2026-03-30. Applicant: Baebies, Inc.. Device class: 2.
Summary
Baebies' FINDER Flu A&B/SARS-CoV-2 Test is filed under QOF, multi-target respiratory specimen nucleic acid tests that include SARS-CoV-2 and other microbial agents. The record doesn't describe the test beyond its name and that code name.
Class II, 21 CFR 866.3981. Microbiology is both the classification panel and the review panel. The record lists the submission type as Dual Track.
Baebies filed from Durham, North Carolina. The decision came 252 calendar days after FDA received it (July 21, 2025 to March 30, 2026).
Clearance details
- Applicant
- Baebies, Inc.
- Product code
- Product code QOF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Durham, NC, US
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