Product Classification

• Device: dengue virus antigen assay
• Regulation Description: Dengue virus serological reagents.
• Definition: Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection
• Physical State: ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.
• Technical Method: Immunoassay e.g., ELISA
• Target Area: Human serum or plasma or whole blood or body fluid collected from patient
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: QCU
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3945
• Device Class: 2
• 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

• Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible