OYPClass II

Anti-jcv Antibody Detection Assay

Microbiology · 21 CFR 866.3336

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.

MDR events2All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances2All time

Recent MDR events

2 adverse event reports on file

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PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMPDec 20, 2022
MalfunctionMedtronic Minimed2032227-2022-382224
STRATIFY JCV DXSELECT ASSAYJan 23, 2015
InjuryFocus Diagnostics, Inc.2023365-2015-00001

Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

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Focus Diagnostics, Inc.1 Medtronic Minimed1

Recalls

1 recall events for this product code

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Focus Diagnostics Inc
TerminatedApr 17, 2015
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
Z-1454-2015 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

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510(k) clearances

2 clearances for this product code

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