13 results
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19ms
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Sources: EU EUDAMED, US FDA
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
FDA Enforcement
Class I
·Terminated·Abbott Diabetes Care, Inc.·December 25, 2013
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014
Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·May 22, 2019
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·May 22, 2019
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019