Panels › Microbiology › Product code QOF · Class 2
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Regulation 866.3981
8510(k)s in 12 months (37 all time)
3recalls in 12 months (9 all time)
4recalls that name a 510(k)
Top companies in QOF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics | 7 | 6 |
| Cepheid | 6 | 0 |
| Hologic, Inc. | 3 | 1 |
| Roche Molecular Systems, Inc. | 4 | 0 |
| Diasorin Molecular, LLC | 3 | 0 |
| QIAGEN GmbH | 3 | 0 |
| Baebies, Inc. | 2 | 0 |
| Nuclein, LLC | 1 | 1 |
| Abbott Molecular, Inc. | 1 | 0 |
| Autonomous Medical Devices Incorporated | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2026 | BioFire Diagnostics, LLC BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742
UDI code: 00815381020529
PCR-based multiplexed nucleic acid test, in vitro diagnostic Open, Classified |
QOF | None listed |
| May 6, 2026 | BioFire Diagnostics, LLC Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485 Open, Classified |
QOF | K232954 |
| Nov 26, 2025 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Open, Classified |
QOF | None listed |
| Aug 6, 2025 | Nuclein LLC DASH SARS-CoV-2 & Flu A/B Test
Model/Catalog Number: SG-0006
combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided t Open, Classified |
QOF | K241652 |
| Mar 31, 2025 | Qiagen Sciences LLC Brand Name: QIAstat-Dx
Product Name: QIAstat-Dx Respiratory Panel Plus
Reference Number (REF): 691224
Software Version: n/a
Component: n/a Open, Classified |
QOF | K233100 |
| Dec 20, 2024 | Hologic, Inc. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 Open, Classified |
QOF | K222736 |
| Jan 10, 2024 | BioFire Diagnostics, LLC The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems. Open, Classified |
QOF | None listed |
| Aug 21, 2023 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only Open, Classified |
QOF | None listed |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 Open, Classified |
QOF | None listed |
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