Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

Dimension Vista® Testosterone Calibrator

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414948775·Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x ...

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

CANDIDA IMMUNODIFFUSION KIT #CA1001

FDA 510(k)

FDA Class 2 ·Microbiology

FUNGAL IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNODIFFUSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES ANTIGEN #CF10023X

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

DBS-ADX

Basic UDI-DI

EU MDR · Eu Md Class 2a ·12 devices

CDX-100

Basic UDI-DI

EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-100

Basic UDI-DI

EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device