MYI

System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Product code: MYI
Device name: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device class: Class 2
21 CFR: 21 CFR 866.1640
Medical specialty: Microbiology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 10 (all years; only the last 3 years are listed here)

Official FDA classification page: MYI

Classification and pathway per current FDA publications. Data from openFDA (CC0).