Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

Cardiac Marker Multi Control

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Bureau Medica Intercert DK

Authorized representative

🇩🇰 Denmark·2 Manufacturers

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) Assay.

Scandinavian Frames Sweden AB

Importer

🇸🇪 Sweden·7 Manufacturers

Agfa NV

Importer

🇧🇪 Belgium·8 Manufacturers

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Orthana GmbH

Importer

🇩🇪 Germany·12 Manufacturers

Ortho Organizers GmbH

Importer

🇩🇪 Germany·34 Manufacturers

Analyzer

FDA registration

Diamond Diagnostics Inc.·29 products·🇭🇺 Hungary

Medtronic B.V.

Importer

🇳🇱 Netherlands·36 Manufacturers

Wellkang Ltd

Authorized representative

259 Manufacturers·3500 Devices

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices