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) K243931
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K243931 for 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), Substantially Equivalent on 2025-03-14. Applicant: Centers for Disease Control and Prevention.
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Code OZE
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.