FDA 510(k) Applications Submitted by DiaSorin Molecular LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN230092 |
12/28/2023 |
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) |
DiaSorin Molecular LLC |
| K190219 |
02/04/2019 |
Simplexa VZV Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
| K220963 |
04/01/2022 |
Simplexa COVID-19 & Flu A/B Direct |
DiaSorin Molecular LLC |
| K201505 |
06/05/2020 |
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack |
DiaSorin Molecular LLC |
| K192376 |
08/30/2019 |
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
| K182467 |
09/10/2018 |
Simplexa GBS Direct, Simplexa GBS Positive Control Pack |
DiaSorin Molecular LLC |
| K202755 |
09/21/2020 |
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack |
DiaSorin Molecular LLC |
| K173498 |
11/13/2017 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
| K183223 |
11/20/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
| K173798 |
12/14/2017 |
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
DiaSorin Molecular LLC |
| K212147 |
07/09/2021 |
Simplexa COVID-19 Direct |
DiaSorin Molecular LLC |
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