CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more— 510(k) K243274
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K243274 for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more, Substantially Equivalent on 2025-07-11. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Clearance details
- Device name as filed
- 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)
- 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
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code OZE
view all- K263035 — 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)
- K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- K230236 — Lyra Influenza A+B Assay
- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
More clearances from Centers for Disease Control and Prevention
view allData sourced from openFDA. This site is unofficial and independent of the FDA.