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U.S. Department of Health and Human Services

Product Classification

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Device dengue serological reagents
Regulation Description Dengue virus serological reagents.
Definition Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.
Physical State Kits
Technical Method Immunological method/ELISA
Target Area Human serum
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOSU
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible