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Anti-Jcv Antibody Detection Assay

FDA product code OYP · Class 2 · Microbiology

3
Registered devices
2
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

STRATIFY JCV™ DXSELECT™ — DIASORIN MOLECULAR LLCIMMUNOWELL JCV IgG Test — GenBioSTRATIFY JCV™ DXSELECT™ — DIASORIN MOLECULAR LLC

Recent recalls

DateFirmReason
2015-03-15Focus Diagnostics IncFocus 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. Thi

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