COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Alinity i Active-B12 (Holotranscobalamin)

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

Carolina Liquid Chemistries

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·2 products·🇬🇧 United Kingdom

3-Reagent Homocysteine Assay for SYNCHRON and UniCel

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

ADVIA Centaur anti-CCP (aCCP) Master Curve Materials (MCM)

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

ABBOTT ARCHITECT 2nd Generation Testosterone

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

N Latex HCY

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

Axis-Shield Active-B12 (Holotranscobalmin)

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

ARCHITECT 2nd Generation Testosterone

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

Alere NT-proBNP for Alinity i Reagent

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

Alinity I Anti-CCP Calibrators

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

Axis-Shield Anti-CCP

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

Alinity I 2nd Generation Testosterone Controls

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

ADVIA Centaur® Calcitonin (CALCT) assay

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom

Alinity I Anti-CCP Controls

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·1 product·🇬🇧 United Kingdom