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U.S. Department of Health and Human Services

Product Classification

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Device serology tests used for infectious disease screening of blood and plasma donations
Regulation Description Test requirements.
Definition For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
Physical State May include reagents, buffers, tubes, plates and other components necessary to run the assay
Technical Method Enzyme-linked immunosorbant assay, chemiluminescence, other antibody-antigen interaction and detection
Target Area Human specimens including blood, serum, plasma, urine, other samples
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQHM
Premarket Review Center for Biologics Evaluation & Research (CBER)
Unclassified Reason Pre-Amendment
Submission Type Contact ODE
Regulation Number 610.40
Device Class Unclassified
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