Documento fuente o registro público
FDA 510(k) K233358 — SCoV-2 Ag Detect Rapid Test
FDA 510(k) index record K233358. Device: SCoV-2 Ag Detect Rapid Test. Applicant as listed: InBios International, Inc.. Decision date: 2024-08-23.
Fuente
"device_name": "SCoV-2 Ag Detect Rapid 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
2026-10-20
professional use
FDA 510(k) public index record K233358.
Device name: SCoV-2 Ag Detect Rapid Test. Applicant as listed: InBios International, Inc..
Decision date: 2024-08-23. Decision wording: Substantially Equivalent.
Product code: QVF. Regulation: 21 CFR 866.3982. 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.