8,769 results · 40ms · Sources: EU EUDAMED, US FDA

Premier Medical Ltd.

Importer
🇮🇪 Ireland·6 Manufacturers

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification
FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Dimension GGT Flex

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

COBAS INTEGRA REAGENT CASSETTES

FDA registration
ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany

Medalist

FDA registration
UNIQUESEA PRODUCTS·1 product·🇹🇭 Thailand

Medalist

FDA registration
QBAS CO., LTD.·1 product·🇹🇼 Taiwan

Disposable SpO2 Sensors, Model: A1411-SA02C

FDA registration
APK TECHNOLOGY CO., LTD·1 product·🇨🇳 China

BeMedico NV

Importer
🇧🇪 Belgium·11 Manufacturers

Dimension Vista GGT Flex

FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS INC.·20 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

PROCLINIC SAU

Importer
🇪🇸 Spain·33 Manufacturers

CEpartner4U

Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices

Plandent Oy

Importer
🇫🇮 Finland·43 Manufacturers

Medical Technology Promedt Consulting GmbH

Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices

COBAS INTEGRA SYSTEM

FDA registration
ROCHE DIAGNOSTICS GMBH·62 products·🇩🇪 Germany

COBAS INTEGRA SYSTEM

FDA registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD.·62 products·🇨🇭 Switzerland