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U.S. Department of Health and Human Services

Product Classification

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Device babesia spp. serological reagents
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.
Physical State Capture antigen substrates (e.g., slides, plates, strips), secondary reagents/conjugates, positive/negative controls, sample diluents, buffers, and media.
Technical Method Target antibodies are captured by antigen preparations and detected with secondary reagents/conjugates.
Target Area IgG and/or IgM antibodies to Babesia spp.
Review Panel Microbiology
Product CodeQIN
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible