Bindazyme Clq Cic Eia Kit

• • Terminated Z-1942-2010 FDA Unclassified (pre-2012) ·initiated 28 Oct 2009

  The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".

510(k) Number

K031563 ↗

FDA Product Code

DAK

Device Class

Class II

Regulation

21 CFR Part 866.5240

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Iga Minineph Antiserum

  Class II

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• Anticardiolipin Iga Screen Eia Diagnostic Test Kit

  Class II

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• Human Protein S Rid Test Kit

  Class II

  FDA 510(k) K951640 Active Cleared 21 Apr 1997

See all devices from The Binding Site, Ltd. →