Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD

Synermed IR500 Chemistry Analyzer IVD

FDA registration

Infrared Laboratory Systems dba SYNERMED·11 products·🇺🇸 United States

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6

Abbott Rapid Dx International Limited

Authorized representative

🇮🇪 Ireland·5 Manufacturers·4 Devices

PICCOLO PRIMARY HEALTH PANEL

FDA registration

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

Piccolo Renal Function Panel

FDA UDI

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

Piccolo Basic Metabolic Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000311·The Piccolo® Basic Metabolic Panel Plus, used w...

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D

V7 103108 0005

Certificate

IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

V7 103108 0007

Certificate

IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Infinity Creatinine

FDA registration

Fisher Diagnostics·13 products·🇺🇸 United States

SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2

FDA registration

BECKMAN COULTER, INC.·13 products·🇺🇸 United States

ABX PENTRA CO2 RTU

FDA registration

HORIBA ABX SAS·13 products·🇫🇷 France

COBAS INTEGRA REAGENT CASSETTES

FDA registration

ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany

SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2

FDA registration

BECKMAN COULTER, INC.·13 products·🇺🇸 United States

Piccolo MetLac 12 Panel

FDA UDI

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

AKRALAB S.L.U.

Importer

🇪🇸 Spain·8 Manufacturers

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...