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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 and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible