Alere Afinion Lipid Panel

FDA registration

Abbott Diagnostics Technologies AS·4 products·🇳🇴 Norway

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne®Liquid CDx (F1LCDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne®CDx (F1CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

ChekMate™ Strips

FDA UDI

POLYMER TECHNOLOGY SYSTEMS, INC.·00381930860019·ChekMate™ Strips are dry strips that mimic the ...

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

BLOOD COLLECTION, CAPILLARY TUBES

Device

EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

BUFFERS

Device

EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

Determine

Device

EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market

HIV AG/AB COMBI - RT & POC

Device

EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries

CardioChek® Analyzer

FDA UDI

POLYMER TECHNOLOGY SYSTEMS, INC.·00381931709010·The CardioChek® Analyzer is intended for in vit...

CardioChek® Analyzer; Refurbished

FDA UDI

POLYMER TECHNOLOGY SYSTEMS, INC.·00381931782013·The CardioChek® Analyzer is intended for in vit...

CardioChek® PA analyzer

FDA UDI

POLYMER TECHNOLOGY SYSTEMS, INC.·00381931708013·The CardioChek® PA professional analyzer is int...

CardioChek® PA Professional Analyzer, Refurbished

FDA UDI

POLYMER TECHNOLOGY SYSTEMS, INC.·00381931757011·The CardioChek® PA professional analyzer is int...

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx, F1CDx

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx