Product Classification

• Device: assay,enzyme linked immunosorbent,parvovirus b19 igm
• Review Panel: Microbiology
• Product Code: MYM
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19

Third Party Review

Not Third Party Eligible