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)
Centers for Disease Control and Prevention · K243274
FDA-authorized Predetermined Change Control Plan
- Company
- Centers for Disease Control and Prevention
- 510(k)/De Novo #
- K243274
- Decision date
- 2025-07-11
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- I/O expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits input/output expansion to compatible devices
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Want the monitoring teardown?
We read the PCCP 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 Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4), then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
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