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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeOYP
Regulation Number 866.3336
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 1 1

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