Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies

• • Terminated Z-0947-2015 FDA Class II ·initiated 20 Nov 2014

  During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.

510(k) Number

K122197 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Eia Smdp Immunoassay

  Class II

  FDA 510(k) K132631 Active Cleared 29 Aug 2014

• Rheumatoid Factor Immunological Test System

  Class II

  FDA 510(k) K102673 Active Cleared 30 Sep 2011

• Immunocap Thyrlobulin Immunocap

  Class II

  FDA 510(k) K072661 Active Cleared 20 Nov 2007

• Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia Gbm Immunoassay, Elia Anca/Gbm Positive Control 100, Elia Anca/Gbm Po Open recall

  Class II

  FDA 510(k) K140225 Active Cleared 27 Oct 2014

• Cardiolipin Autoantibody Immunological Test System

  Class II

  FDA 510(k) K091845 Active Cleared 7 Jun 2010

• Varelisa Recombi Ana Screen, Model 12 596

  Class II

  FDA 510(k) K083188 Active Cleared 13 Mar 2009

See all devices from Phadia Us Inc. →