Device Listing 1894483267
Listing Summary#
- Listing key
- 1894483267
- Premarket submission
- K252387
- Device
- Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- Applicant
- Diasorin Molecular, LLC
- Product code
- QOF
- Decision date
- 2025-10-30