Simplexa COVID-19 Direct— 510(k) K212147
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K212147 for Simplexa COVID-19 Direct, Substantially Equivalent on 2022-09-13. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code QQX
view all- K243396 — Aptima SARS-CoV-2 Assay
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- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
More clearances from Diasorin Molecular, LLC
view all- K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
- K251978 — LIAISON NES FLU A/B, RSV & COVID-19
- K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K220963 — Simplexa COVID-19 & Flu A/B Direct
Data sourced from openFDA. This site is unofficial and independent of the FDA.