510(k) 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
- 510(k) number
- K252387
- Product code
- QOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-30
- Date received
- 2025-07-31
- Regulation
- 866.3981
- Classification name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Michael Treas
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers
- 3014654360
- 3009613136
- 2243471
- 1528450
- 3008632402
- 3004530258
- 3019837962
- 3009302820
- 2023365
- 2024800
- 3003795116
- 3010770794
- 3006028115
- 3014515702
- 3011057574
- 3021140368
- 3002777243
- 3014553740
- 3011240982
- 3011104381
- 3005248192
- 3035381641
- 3002773840
- 3004013603
- 3016838963
- 3009976420
- 3007420875
- 3006247421
- 1119779
- 3004141078
Source Documents
Other 510(k) Records For Product Code QOF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026-03-30 |
| K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 2026-02-13 |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | 2025-12-23 |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2025-08-27 |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025-08-14 |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025-07-31 |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025-05-01 |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025-05-01 |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 |
| K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | 2025-02-19 |
| K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | 2025-02-14 |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025-01-10 |
| K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | Life Technologies Corporation | 2025-01-08 |
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | 2024-12-20 |