Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems

FDA submissions for Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems in the Medical Genetics (MG) review panel, including product codes and regulations.

Section range: §§ 866.6000–866.6090

CFR Part: 866

Product Codes

Product CodeDevice NameRegulationClassDevices
QNCWhole Exome Sequencing Constituent Device866.600021
OYXBcr/Abl1 Monitoring Test866.606025
PSUJak2 Gene Mutation Detection Test866.607022
QAZCancer Predisposition Risk Assessment System866.609024
Innolitics

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