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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


Premarket Reviews
ManufacturerDecision
FOCUS DIAGNOSTICS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2022 1 1

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

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

Recalls
Manufacturer Recall Class Date Posted
1 Focus Diagnostics Inc II Apr-17-2015
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