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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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Autokit CH50 - 00856626006113

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
Not in Commercial Distribution

  • 00856626006113 ()
995-40801

  • Total complement activity (CH50) IVD, reagent

Autokit Micro Albumin Calibrator Set - 00856626006106

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
Not in Commercial Distribution

  • 00856626006106 ()
995-06101

  • Microalbumin IVD, calibrator

uTASWako DCP Calibrator Set - 00856626006212

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
Not in Commercial Distribution

  • 00856626006212 ()
999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

Cleaning Solution with additive S7375 REF 944-123 - 05700699441232

S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system

AUTOCHECK 6+, LEVEL 4, S7865 - 05700699440976

S7865 AutoCheck 6+, level 4 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-097
In Commercial Distribution

  • 55700699440971 ()
  • 05700699440976 ()
944-097

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

AUTOCHECK 6+, LEVEL 3, S7855 - 05700699440969

S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-096
In Commercial Distribution

  • 55700699440964 ()
  • 05700699440969 ()
944-096

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

AUTOCHECK 6+, LEVEL 2, S7845 - 05700699440952

S7845 AutoCheck 6+, level 2 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-095
In Commercial Distribution

  • 55700699440957 ()
  • 05700699440952 ()
944-095

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

AUTOCHECK 6+, LEVEL 1, S7835 - 05700699440945

S7835 AutoCheck 6+, level 1 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-094
In Commercial Distribution

  • 55700699440940 ()
  • 05700699440945 ()
944-094

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

D8088+D8089 Crea membrane A+B - 05700699420732

D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution

  • 05700699420732 ()
942-073

  • Creatinine IVD, reagent

Membrane for E7077 electrode - 05700699420664

D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution

  • 05700699420664 ()
  • 55700699420669 ()
942-066

  • Lactate electrode IVD
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