Captia Measles Igm

• • Terminated Z-1503-2021 FDA Class II ·initiated 17 Mar 2021

  Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

• • Terminated Z-2782-2016 FDA Class III ·initiated 11 Jul 2016

  The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

510(k) Number

K140455 ↗

FDA Product Code

PCL

Device Class

Class I

Regulation

21 CFR Part 866.3520

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Captia™ Cytomegalovirus IgM kit

  IVD General

  CE/IVDD

• Chlamydia Igg Elisa Test System

  Class I

  FDA 510(k) K033079 Active Cleared 26 Nov 2003

• Borrelia Burgdorferi IgM ELISA Test System

  Class II

  FDA 510(k) K033070 Active Cleared 26 Nov 2003

• ENA Profile ELISA Test System

  Class II

  FDA 510(k) K993839 Active Cleared 12 Jan 2000

• Borrelia Burgdorferi IgG/IgM ELISA Test System

  Class II

  FDA 510(k) K033083 Active Cleared 26 Nov 2003

• Pylori Igg

  Class I

  FDA 510(k) K033067 Active Cleared 26 Nov 2003

See all devices from Trinity Biotech USA →