Source document or public record
FDA 510(k) K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
FDA 510(k) index record K192376. Device: Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2019-11-26.
Source
"device_name": "Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K192376.
Device name: Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack. Applicant as listed: Diasorin Molecular, LLC.
Decision date: 2019-11-26. Decision wording: Substantially Equivalent.
Product code: PGI. Regulation: 21 CFR 866.3309. 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.