Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Symptomtjekker

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ODA ApS·1 device

Medicintjekker

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ODA ApS·1 device

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

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/ENTITY/IDENTITY ADX/INTREGRITY/INTEGRITY MICRO/VERITY ADX PACEMAKERS

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx Assay

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX DEVICE

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx Device

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)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)