FDA Product Code
FDA Product Code QOF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3981
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263120 | Xpert Xpress CoV-2/Flu plus | Cepheid® | 2026-10-02 | Special | PDF ↗ |
| K261336 | Xpert Respiratory Panel | Cepheid | 2026-09-25 | Traditional | PDF ↗ |
| K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | 2026-09-22 | Special | PDF ↗ |
| K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | 2026-06-12 | Dual Track | PDF ↗ |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026-03-30 | Dual Track | PDF ↗ |
| K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 2026-02-13 | Dual Track | PDF ↗ |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | 2025-12-23 | Dual Track | PDF ↗ |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC | 2025-10-30 | Traditional | PDF ↗ |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2025-08-27 | Traditional | PDF ↗ |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025-08-14 | Dual Track | PDF ↗ |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025-07-31 | Traditional | PDF ↗ |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025-05-01 | Special | PDF ↗ |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2025-05-01 | Special | PDF ↗ |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 | Dual Track | PDF ↗ |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 | Dual Track | PDF ↗ |
| K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | 2025-02-19 | Dual Track | PDF ↗ |
| K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | 2025-02-14 | Traditional | PDF ↗ |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025-01-10 | Dual Track | PDF ↗ |
| K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | Life Technologies Corporation | 2025-01-08 | Traditional | PDF ↗ |
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | 2024-12-20 | Dual Track | PDF ↗ |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K242353 | QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH | 2024-10-25 | Special | PDF ↗ |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024-07-18 | Traditional | PDF ↗ |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024-05-30 | Special | PDF ↗ |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH | 2024-05-10 | Traditional | PDF ↗ |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024-03-26 | Dual Track | PDF ↗ |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. | 2024-03-11 | Traditional | PDF ↗ |
| K233410 | LIAISON PLEX Respiratory Flex Assay | Luminex Corporation | 2024-03-01 | Traditional | PDF ↗ |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2023-08-17 | Traditional | PDF ↗ |
| K230956 | BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System | Bd Integrated Diagnostic Solutions / | 2023-07-31 | Traditional | PDF ↗ |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | Roche Molecular Systems, Inc. | 2023-07-27 | Dual Track | PDF ↗ |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023-05-16 | Traditional | PDF ↗ |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023-04-13 | Special | PDF ↗ |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | Diasorin Molecular, LLC | 2023-03-17 | Traditional | PDF ↗ |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023-02-03 | Dual Track | PDF ↗ |
| DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021-03-17 | Direct | — |
Product code QOF · Class II · Microbiology. Data: openFDA.