Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) CDx Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

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

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278560049·Software Pristina 8.1 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278009289·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682145862·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682142373·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278711229·UDI Software Pristina

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682143516·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682146845·Software Pristina Infinity

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278655141·Software Pristina 8.2 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278795724·Software Pristina 8.3 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278716026·UDI Software Pristina ME 9.1

T4 RIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T-4 RIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMPULSE T4 ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry