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

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UniCel DxI 600 Access Immunoassay System w/Spot B

Device

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

UniCel DxI 800 Access Immunoassay System w/Spot B

Device

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

NA

FDA UDI

MEDTRONIC, INC.·00643169431874·CABLE 5103 ROHS GLBL 10L

NA

FDA UDI

MEDTRONIC, INC.·00643169838604·ADAPTOR CABLE 5103 US

NA

FDA UDI

MEDTRONIC, INC.·00763000181215·ADAPTOR CABLE 5103

HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

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

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

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

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

St Jude Medical MR Conditional Pacemaker System

FDA registration

Abbott Medical·3 products·🇺🇸 United States

Merlin@Home

FDA registration

Plexus Manufacturing Sdn. Bhd.·3 products·🇲🇾 Malaysia

biologic material, dental Straumann Emdogain 0.7 ml, Multipack

FDA registration

Sterigenics Radiation Technologies, LLC·3 products·🇺🇸 United States

St Jude Medical MR Conditional Pacemaker System

FDA registration

ABBOTT MEDICAL·3 products·🇺🇸 United States