11220-2017-CE-KOR-NA-PS

Certificate

MDD Annex II (excluding section 4)·JW Pharmaceutical Corporation·DNV Product Assurance AS·5 Basic UDI-DIs

Jazz Pharmaceuticals PLC

Authorized representative

🇮🇪 Ireland·1 Manufacturer

PICCOLO 9-CHEM REAGENT ROTOR

FDA registration

ABAXIS, INC.·9 products·🇺🇸 United States

Piccolo Liver Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000031·The Piccolo® Liver Panel Plus, used with the Pi...

NVT GmbH

Authorized representative

🇩🇪 Germany·3 Manufacturers·185 Devices

Dimension GGT Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·11 products·🇺🇸 United States

Piccolo Renal Function Panel

FDA UDI

ABAXIS, INC.·EABA40000271·The Piccolo® Renal Function Panel, used with th...

PICCOLO PRIMARY HEALTH PANEL

FDA registration

ABAXIS, INC.·12 products·🇺🇸 United States

CONDUCTOR (CONDUCT OR)

FDA registration

PENTAX of America, Inc.·1 product·🇺🇸 United States

Piccolo MetLac 12 Panel

FDA UDI

ABAXIS, INC.·EABA40000371·The Piccolo® MetLac 12 Panel reagent disc, used...

Piccolo AmLyte 13

FDA UDI

ABAXIS, INC.·EABA40000411·The Piccolo® AmLyte 13 , used with the Piccolo ...

Piccolo BioChemistry Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000351·The Piccolo® BioChemistry Panel Plus, used with...

Piccolo General Chemistry 13

FDA UDI

ABAXIS, INC.·EABA40000291·The Piccolo® General Chemistry 13 used with the...

Piccolo Comprehensive Metabolic Panel

FDA UDI

ABAXIS, INC.·EABA40000281·The Piccolo® Comprehensive Metabolic Panel, use...

UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS TOTAL PROTEIN

FDA registration

DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI·17 products·🇹🇷 Türkiye

467858 SYNCHRON Systems Albumin Reagent

FDA registration

BECKMAN COULTER, INC.·17 products·🇺🇸 United States

467858 SYNCHRON Systems Albumin Reagent

FDA registration

Beckman Coulter Ireland Inc·17 products·🇮🇪 Ireland

467858 SYNCHRON Systems Albumin Reagent

FDA registration

BECKMAN COULTER, INC.·17 products·🇺🇸 United States

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States

442765 Albumin Reagent (ALB 2 x 300)

FDA registration

BECKMAN COULTER, INC.·63 products·🇺🇸 United States