Documento fuente o registro público
FDA 510(k) K261837 — FINDER Flu A&B/SARS-CoV-2 Test
FDA 510(k) index record K261837. Device: FINDER Flu A&B/SARS-CoV-2 Test. Applicant as listed: Baebies, Inc.. Decision date: 2026-09-11.
Fuente
"device_name": "FINDER Flu A&B/SARS-CoV-2 Test"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-22
professional use
FDA 510(k) public index record K261837.
Device name: FINDER Flu A&B/SARS-CoV-2 Test. Applicant as listed: Baebies, Inc..
Decision date: 2026-09-11. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.