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U.S. Department of Health and Human Services

Product Classification
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Device multiplex flow immunoassay, t. gondii, rubella, cmv igm
Regulation Description Rubella virus serological reagents.
Definition The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
Physical State In-vitro diagnostic kit.
Technical Method The device utilizes multiplex fluorescence technology.
Target Area Human serum / plasma
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePUQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3510
Device Class 2
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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