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U.S. Department of Health and Human Services

Product Classification
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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 CodeNWY
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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