Product code QIN

Device name

Babesia Spp. Serological Reagents

Medical specialty

Unknown

Device class

N

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset