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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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ADVIA Centaur IL6 Control - 00630414010472

No Description
Siemens Healthcare Diagnostics Inc.
10995083
In Commercial Distribution

  • 00630414010472 ()
10995083

  • Interleukin-6 (IL-6) IVD, control

Triage - 30014613338048

Triage PLGF Test (OUS)
QUIDEL CARDIOVASCULAR INC.
98800EU
In Commercial Distribution

  • 30014613338048 ()
98800EU

  • Placental growth factor (PLGF) IVD, kit, fluorescent immunoassay

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640123

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640123 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640116

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640116 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640024

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640024 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640017

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640017 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

ADVIA Centaur ® IL6 100T Kit - 00630414010434

ADVIA Centaur ® IL-6 100T Kit
Siemens Healthcare Diagnostics Inc.
10995080
In Commercial Distribution

  • 00630414010434 ()
10995080

  • Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay

REAL Immersive System - 00815948024229

REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative

Spirochete - 00847627001566

No Description
BIOCARE MEDICAL LLC
ACI135C
In Commercial Distribution

  • 00847627001566 ()


  • Treponema pallidum antigen IVD, antibody

Spirochete - 00847627001559

No Description
BIOCARE MEDICAL LLC
ACI135B
In Commercial Distribution

  • 00847627001559 ()


  • Treponema pallidum antigen IVD, antibody
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