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U.S. Department of Health and Human Services

Product Classification

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Device multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus
Definition The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.
Physical State The device is a fully automated instrument
Technical Method Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)
Target Area The device is an in-vitro diagnostic device; none of the body parts will utilize the device or is intended to be affected by the device
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOPL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons