Centers for Disease Control and Prevention
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories4
Latest FDA decision2026-03-30
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260812 | Francisella tularensis Real-time PCR Assay | SGA | 2026-03-30 | View |
| 510(k) | K252072 | Francisella tularensis Real-time PCR assay | SGA | 2025-09-30 | View |
| 510(k) | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | 2025-07-11 | View |
| 510(k) | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | 2025-03-14 | View |
| 510(k) | K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | OZE | 2024-05-21 | View |
| 510(k) | K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-08-30 | View |
| 510(k) | K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-06-24 | View |
| 510(k) | K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-06-10 | View |
| 510(k) | K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | OZE | 2020-03-10 | View |
| 510(k) | K192871 | B. anthracis Real-time PCR Assay | NHT | 2019-11-07 | View |
| 510(k) | K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit | OZE | 2019-03-27 | View |
| 510(k) | K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2018-09-20 | View |
| 510(k) | K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | OZE | 2017-08-09 | View |
No matching devices.