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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No Description
LIFE TECHNOLOGIES CORPORATION
A54626
In Commercial Distribution

  • 10190302018449 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A52649, V2.0.0
In Commercial Distribution

  • 10190302018159 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A52015, V1.0.5
In Commercial Distribution

  • 10190302017862 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51222
In Commercial Distribution

  • 10190302017336 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51220
In Commercial Distribution

  • 10190302017329 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51197
In Commercial Distribution

  • 10190302016162 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51195
In Commercial Distribution

  • 10190302016155 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A50745
In Commercial Distribution

  • 10190302016148 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A47324
In Commercial Distribution

  • 10190302015592 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
ION ONE TOUCH ES DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH ES DX
In Commercial Distribution

  • 10190302000864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
ION ONE TOUCH DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH DX
In Commercial Distribution

  • 10190302000857 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
LAMP,HALOGEN RC, IVD
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
4480914
In Commercial Distribution

  • 10190302000734 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
8788
In Commercial Distribution

  • 10190302000697 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
VERITI DX 384W THERMAL CYCLER
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9913
In Commercial Distribution

  • 10190302000536 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9912
In Commercial Distribution

  • 10190302000529 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
VERITI DX 96W FAST THERM CYCLR
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9911
In Commercial Distribution

  • 10190302000512 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
7503
In Commercial Distribution

  • 10190302000222 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Universal IPPB Circuit
TELEFLEX INCORPORATED
IPN913682
In Commercial Distribution

  • 24026704645767 ()
  • 14026704645760 ()
1560

  • Ventilator breathing circuit, single-use
Refurbished IVD Instrument (FilmArray® Torch Module)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0003-W
In Commercial Distribution

  • 00815381029089 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch System Base)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0001-W
In Commercial Distribution

  • 00815381029072 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001-W
In Commercial Distribution

  • 00815381029058 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002-W
In Commercial Distribution

  • 00815381020376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002
In Commercial Distribution

  • 00815381020369 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001-W
In Commercial Distribution

  • 00815381020352 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD instrument (Torch Module)
BIOFIRE DIAGNOSTICS, LLC
HTFA-SUB-0103
Not in Commercial Distribution

  • 00815381020284 ()
HTFA-SUB-0103R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Torch Module).
BIOFIRE DIAGNOSTICS, LLC
HTFA-SUB-0103
In Commercial Distribution

  • 00815381020277 ()
HTFA-SUB-0103

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch System Base).
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0104
Not in Commercial Distribution

  • 00815381020260 ()
HTFA-ASY-0104R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Torch System Base).
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0104
In Commercial Distribution

  • 00815381020253 ()
HTFA-ASY-0104

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001
In Commercial Distribution

  • 00815381020055 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
Not in Commercial Distribution

  • 00815381020048 ()
FLM2-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
In Commercial Distribution

  • 00815381020031 ()
FLM2-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020024 ()
FLM1-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Instrument)
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020017 ()
FLM1-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ SDA Extraction Reagent Trough
BECTON, DICKINSON AND COMPANY
441994
In Commercial Distribution

  • 30382904419944 ()
  • 00382904419943 ()
441994

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper Neutralization Pouch
BECTON, DICKINSON AND COMPANY
441354
In Commercial Distribution

  • 30382904413546 ()
  • 00382904413545 ()
441354

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 01812125010067 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Automated PCR analyzer
DXNA LLC
91004001
In Commercial Distribution

  • A91004001 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD PCR Cartridges 24EA
BECTON, DICKINSON AND COMPANY
437519
In Commercial Distribution

  • 30382904375196 ()
  • 00382904375195 ()
437519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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