Panels › Immunology › Product code QVR · Class 2
Multiplex Nucleic Acid Detection System For Biothreat Agents
Regulation 866.4000
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QVR
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Defense, LLC | 1 | 0 |
| Cepheid | 1 | 0 |
| T2biosystems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K261362 | Xpert Hemorrhagic Fever Cepheid | QVR |
| Sep 15, 2023 | K231336 | T2 Biothreat Panel T2biosystems, Inc. | QVR |
| Mar 22, 2023 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Biofire Defense, LLC | QVR |
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