De Novo Classifications

FDA submissions for De Novo Classifications in the Microbiology (MI) review panel, including product codes and regulations.

Section range: §§ 866.2952–866.4002

CFR Part: 866

Product Codes

Product CodeDevice NameRegulationClassDevices
QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples866.295221
QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens866.400221
Innolitics

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