MINUTEX D-DIMER LATEX TEST

FDA 510(k)

FDA Class 2 ·Hematology

BIOPOOL PROTEIN C EID KIT AND BULK PLATES

FDA 510(k)

FDA Class 2 ·Hematology

ALPHA

FDA 510(k)

FDA Class 2 ·Radiology

SPECTROLYSE ANTIPLASMIN KIT

FDA 510(k)

FDA Class 2 ·Hematology

VIDEO FLUOROSCOPE

FDA 510(k)

FDA Class 2 ·Radiology

BIOCLOT C KIT

FDA 510(k)

FDA Class 2 ·Hematology

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES

FDA 510(k)

FDA Class 2 ·Hematology

SPECTROLYSE PROTEIN C KIT

FDA 510(k)

FDA Class 2 ·Hematology

BIOCLOT LA

FDA 510(k)

FDA Class 1 ·Hematology

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Contrast Media, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

DZ-Tabone Intervertebral Body Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

s LDL-EX SEIKEN

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LDL Cholesterol

Basic UDI-DI

EU IVDD · Eu Ivd General ·C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.·1 device

LDL-Cholesterol

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Medicon Hellas SA·5 devices

LDL-Cholesterol

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Thermo Fisher Scientific Oy·1 device

LDL-Cholesterol

Basic UDI-DI

EU IVDD · Eu Ivd General ·Thermo Fisher Scientific Oy·1 device

LDL Cholesterol

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

LDL Cholesterol

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

Cholestech LDX

FDA registration

Alere San Diego, Inc.·5 products·🇺🇸 United States