Abbott Ireland Diagnostics Division — FDA Profile

Summary

Number	Class	Product	Date
Z-1353-2019	Class II	Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemilumi	February 5, 2019
Z-1354-2019	Class II	Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminesc	February 5, 2019
Z-0668-2019	Class II	Alinity i Progesterone Reagent Kit, List Number 08P3620	November 21, 2018
Z-0666-2019	Class II	Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121	November 21, 2018
Z-0669-2019	Class II	Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532	November 21, 2018
Z-0667-2019	Class II	Alinity i Estradiol Reagent Kit, List Number 07P5020	November 21, 2018
Z-0665-2019	Class II	Alinity i Free T4 Reagent Kit, List Number 07P7030	November 21, 2018
Z-2208-2019	Class II	Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemilumin	November 21, 2018
Z-0664-2019	Class II	Alinity i TSH Reagent Kit, List Number 07P4830	November 21, 2018
Z-0799-2019	Class II	ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage	October 12, 2018
Z-0798-2019	Class II	ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage:	October 12, 2018
Z-0474-2015	Class II	ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (	September 11, 2014