Source document or public record
FDA 510(k) K212147 — Simplexa COVID-19 Direct
FDA 510(k) index record K212147. Device: Simplexa COVID-19 Direct. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2022-09-13.
Source
"device_name": "Simplexa COVID-19 Direct"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K212147.
Device name: Simplexa COVID-19 Direct. Applicant as listed: Diasorin Molecular, LLC.
Decision date: 2022-09-13. Decision wording: Substantially Equivalent.
Product code: QQX. 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.
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