510(k) K263035 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
| Applicant | Centers for Disease Control and Prevention, Atlanta GA, US |
| Decision | Substantially Equivalent, Sep 30, 2026 |
| Received | Aug 31, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263035
No recall in the FDA data names this 510(k).
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