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Simplexa COVID-19/ Flu A/B & RSV Direct - Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
FDA 510(k)Class II (US FDA 510(k))
510(k) K252387
Identifiers
- 510(k) Number
- K252387 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
- Models / Variants
- Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Simplexa COVID-19/ Flu A/B & RSV Direct - Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450) by DiaSorin Molecular LLC — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252387 | Class II | Active |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
- FDA Applicant
- Diasorin Molecular, LLC
Sources (1)
- FDA 510(k) K252387 24 fields · synced Jun 18, 2026