Product Classification

• 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 Code: QHM
• 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible