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U.S. Department of Health and Human Services

Product Classification

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Device anti-jcv antibody detection assay
Definition The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies.
Physical State Reagent kit.
Technical Method A serological test for the detection of the presence on anti-JCV specific antibodies in serum or plasma samples by an enzyme linked immunosorbent technology
Target Area In-vitro diagnostic test
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOYP
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3336
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