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U.S. Department of Health and Human Services

Product Classification
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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 CodeQCU
Premarket Review Division of Microbiology Devices (DMD)
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
Third Party Review Not Third Party Eligible
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