T2 Biothreat Panel

FDA registration

T2 BIOSYSTEMS, INC.·3 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

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

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

T2 Biothreat Panel

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

T2Biothreat® QCheck Negative Kit

FDA UDI

T2 BIOSYSTEMS, INC.·M70885113983·Negative quality control for T2Biothreat Panel

T2Biothreat® Reagent Trays

FDA UDI

T2 BIOSYSTEMS, INC.·M70880113943·The T2Biothreat Panel component that contains t...

Vysis

FDA UDI

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

T2Biothreat® Cartridge Kit

FDA UDI

T2 BIOSYSTEMS, INC.·M70890114000·The T2Biothreat Panel components used to load t...