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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Bioness Integrated System (BITS)2.0.5 - 00815962020238

Bioness Integrated Therapy System, Version 2.0, 48" Display with Software
BIONESS INC.
BIT-2048
In Commercial Distribution

  • 00815962020238 ()


  • Perceptual-coordination assistive training device

Bioness Integrated System (BITS)2.0.5 - 00815962020221

Bioness Integrated Therapy System, Version 2.0, 55" Display with Software
BIONESS INC.
BIT-2055
In Commercial Distribution

  • 00815962020221 ()


  • Perceptual-coordination assistive training device

SmartCycler Dx System - 07332940004910

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N17-1
In Commercial Distribution

  • 07332940004910 ()
SC2500N17-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004903

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N18-1
In Commercial Distribution

  • 07332940004903 ()
SC2500N18-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004880

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N19-1
In Commercial Distribution

  • 07332940004880 ()
SC2500N19-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004866

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N2-1
In Commercial Distribution

  • 07332940004866 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004842

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1
In Commercial Distribution

  • 07332940004842 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004835

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1R
In Commercial Distribution

  • 07332940004835 ()
SC2500N3-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004804

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1
In Commercial Distribution

  • 07332940004804 ()
SC2500N4-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004798

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1R
In Commercial Distribution

  • 07332940004798 ()
SC2500N4-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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