QHM

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Product code: QHM
Device name: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
Device class: Class U
21 CFR: 21 CFR 610.40
Medical specialty: Microbiology
Marketing pathway: Contact ODE

FDA classification definition

For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QHM

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