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IMMUNOWELL JCV IgG Test

GenBio · Model 804-3810 · UDI-DI 00613745002231

OYP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is intended for use, in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations.

Recalls

Date	Firm	Reason
2015-03-15	Focus Diagnostics Inc	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 po

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.