Documento fuente o registro público
FDA 510(k) K230349 — Lyra RSV+hMPV Assay
FDA 510(k) index record K230349. Device: Lyra RSV+hMPV Assay. Applicant as listed: Quidel Corporation. Decision date: 2023-03-10.
Fuente
"device_name": "Lyra RSV+hMPV Assay"
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
2026-10-29
professional use
FDA 510(k) public index record K230349.
Device name: Lyra RSV+hMPV Assay. Applicant as listed: Quidel Corporation.
Decision date: 2023-03-10. Decision wording: Substantially Equivalent.
Product code: OEM. Regulation: 21 CFR 866.3980. 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.