Device Listing 1388086896

Listing Summary#

Listing key
1388086896
Premarket submission
K243274
Device
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
OZE
Decision date
2025-07-11