PreludeSYNC EZ Radial Compression Device

FDA registration

Merit Medical Australia Pty Ltd.·1 product·🇦🇺 Australia

MEDICAL COMPONENTS INC

FDA registration

MEDICAL COMPONENTS INC·1 product·🇺🇸 United States

ClampEase

FDA registration

ADVANCED VASCULAR DYNAMICS·1 product·🇺🇸 United States

UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

SYNCHRON LX/DxC Blood Urea Nitrogen (BUNm)

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

CHEMISTRY ANALYZER DxC 700 AU with ISE

Device

EU IVDR · Eu Ivd Class A ·Beckman Coulter Inc.·On the market·32 countries

UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

FDA 510(k)

FDA Class 2 ·Immunology

CHEMISTRY ANALYZER DxC 700 AU for Direct Track Sampling

Device

EU IVDR · Eu Ivd Class A ·Beckman Coulter Inc.·On the market·32 countries

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry