Product Classification

• Device: japanese encephalitis virus immunological/serology test
• Definition: Product code for export only
• Physical State: For Export Only
• Technical Method: For Export Only
• Target Area: For Export Only
• Review Panel: Microbiology
• Product Code: SAD
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible