Duet™

FDA UDI

BIO-VIEW LTD·07290107652827·

Duet-3

FDA registration

BIOVIEW LTD.·2 products·🇮🇱 Israel

CEP__DNA Probe Kit and Slides

FDA registration

ABBOTT MOLECULAR, INC.·2 products·🇺🇸 United States

SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

FDA 510(k)

FDA Class 2 ·Immunology

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANEUVYSION

FDA 510(k)

FDA Class 2 ·Immunology

SCANVIEW HER2/NEU FISH SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

GENASIS SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VYSIS AUTOVYSION SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CYTOVISION FOR CEP XY

FDA 510(k)

FDA Class 2 ·Immunology

ARIOL HER-2/NEU FISH

FDA 510(k)

FDA Class 2 ·Immunology

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027077·CEP 8 SpectrumOrange

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027008·CEP 8 SpectrumOrange

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027039·ProbeChek Negative Control 0% Trisomy 8/12

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027046·ProbeChek Positive Control 10% Trisomy 8/12

GenASIs™ System

FDA UDI

APPLIED SPECTRAL IMAGING LTD.·07290016630008·

ASI IVD System

FDA UDI

APPLIED SPECTRAL IMAGING LTD.·07290016630039·ASI IVD System with software version GenASIs V-8.3