Bromcresol Purple Dye-Binding, Albumin

FDA classification

FDA Class 2 ·Bromcresol Purple Dye-Binding, Albumin

AJW Technology Consulting GmbH

Authorized representative

🇩🇪 Germany·18 Manufacturers·23 Devices

TH Oral 249

FDA registration

SMC Costa Rica Division S.R.L.·2 products·🇨🇷 Costa Rica

11220-2017-CE-KOR-NA-PS

Certificate

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

PICCOLO 9-CHEM REAGENT ROTOR

FDA registration

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

Consul 22

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·4 devices

Piccolo Liver Panel Plus

FDA UDI

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

OKO SOLUTION

Importer

🇫🇷 France·11 Manufacturers

DW Commerce GmbH

Authorized representative

🇩🇪 Germany

Inflation Device

Basic UDI-DI

EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·2 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

Piccolo MetLac 12 Panel

FDA UDI

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

EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse

FDA 510(k)

FDA Class 2 ·Orthopedic

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