Product Classification

• Device: test, qualitative, detection of dengue igm and igg antibodies
• Definition: Intended for the detection of igm and igg antibodies to dengue virus in human serum, plasma or whole blood.
• Physical State: In-vitro diagnositc test
• Technical Method: In-vitro diagnostic test
• Target Area: In-vitro diagnostic test
• Review Panel: Microbiology
• Product Code: NWY
• Submission Type: Contact ODE
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

Not Third Party Eligible