GE Discovery MI

FDA registration

Probo Medical Ltd·2 products·🇬🇧 United Kingdom

Discovery MI

FDA registration

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·2 products·🇮🇱 Israel

Columbia 1 Applications

FDA registration

HM PRODUCT SOLUTIONS, LTD.·2 products·🇺🇸 United States

Discovery MI

FDA registration

GE MEDICAL SYSTEMS, LLC·2 products·🇺🇸 United States

Discovery MI

FDA registration

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·2 products·🇮🇱 Israel

Discovery MI

FDA 510(k)

FDA Class 2 ·Radiology

OTF / Gabapentin assay DLJ / Calibrators, drug specific LAS / Drug specific control materials

FDA registration

MONOCENT INC.·3 products·🇺🇸 United States

ARK Gabapentin Assay

FDA registration

ARK DIAGNOSTICS INC·3 products·🇺🇸 United States

Isomedix Operations Inc.

FDA registration

Isomedix Operations Inc.·1 product·🇺🇸 United States

EasyOne Pro/Pro LAB

FDA registration

ZOLLNER ELECTRONICS GMBH·1 product·🇨🇭 Switzerland

Transem Spherical

FDA registration

ORIGIO A/S·1 product·🇩🇰 Denmark

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

FDA 510(k)

FDA Class 2 ·Hematology

System, Tomography, Computed, Emission

FDA classification

FDA Class 2 ·System, Tomography, Computed, Emission

Gabapentin Assay

FDA classification

FDA Class 2 ·Gabapentin Assay

Counter, Differential Cell

FDA classification

FDA Class 2 ·Counter, Differential Cell