QIN

Babesia Spp. Serological Reagents

Product code: QIN
Device name: Babesia Spp. Serological Reagents
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification definition

Tests or reagents used to detect IgG and/or IgM antibodies to Babesia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Babesia spp. in patients suspected of exposure.

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

Official FDA classification page: QIN

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