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Centers for Disease Control and Prevention FDA Approvals
0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Francisella tularensis Real-time PCR Assay510(k)Mar 30, 2026Immunology |
| Francisella tularensis Real-time PCR assay510(k)Sep 30, 2025Immunology |
| 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)510(k)Jul 11, 2025Microbiology |
| 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)510(k)Mar 14, 2025Microbiology |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)510(k)May 21, 2024Microbiology |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set510(k)Aug 30, 2022Microbiology |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set510(k)Jun 24, 2022Microbiology |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set510(k)Jun 10, 2022Microbiology |