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)— 510(k) K263035
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K263035 for 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), Substantially Equivalent on 2026-09-30. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Summary
The applicant here is the Centers for Disease Control and Prevention. The CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel includes four kits: Influenza A/B Typing, Influenza A Subtyping, Influenza A(H5) Subtyping, and Influenza B Lineage Genotyping. It's filed under OZE, influenza A and influenza B multiplex nucleic acid assays.
Class II, 21 CFR 866.3980, Microbiology panel. CDC filed it as a Special 510(k). The record doesn't describe the submission's scope beyond the kit names.
CDC filed from Atlanta, Georgia. Review took 30 days (August 31 to September 30, 2026).
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Product code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
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