Binding Site Igg Sublcass Olympus Kits

• 2 recalls, same reason

  • Terminated Z-1067-2017 FDA Class II ·initiated 11 Sep 2014
  • Terminated Z-1068-2017 FDA Class II ·initiated 11 Sep 2014

  Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

510(k) Number

K042152 ↗

FDA Product Code

CFN

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Alpha-1-Antitrypsin Immunological Nl Test Kit

  Class II

  FDA 510(k) K913666 Active Cleared 9 Dec 1991

• Anti-Tpo Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K984163 Active Cleared 2 Feb 1999

• Ena Screening Cie Kit for Diagnostic Use

  Class II

  FDA 510(k) K924262 Active Cleared 29 Dec 1992

• Iga Minineph Antiserum

  Class II

  FDA 510(k) K981786 Active Cleared 24 Nov 1999

• Anticardiolipin Iga Screen Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K983696 Active Cleared 5 Feb 1999

• 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. →