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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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Crea Calibration Solution 2 - 05700699441348

S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Radiometer Medical ApS
944-134
In Commercial Distribution

  • 15700699441345 ()
  • 05700699441348 ()
944-134

  • Multiple blood gas analyte IVD, calibrator

QUALICHECK 4+, LEVEL 2 - 05700699440549

S7440 QUALICHECK4+, level 2 YELLOW box of 30 ampoules. For ABL300/330, ABL5/50X/555, ABL7X, ABL70X, EML10X, ABL80
Radiometer Medical ApS
944-054
In Commercial Distribution

  • 55700699440544 ()
  • 05700699440549 ()
944-054

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

QUALICHECK 5+, LEVEL 2 - 05700699440181

S7740 QUALICHECK5+, level 2 YELLOW box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X
Radiometer Medical ApS
944-018
In Commercial Distribution

  • 55700699440186 ()
  • 05700699440181 ()
944-018

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

MACH 2 Rabbit AP-Polymer - 00847627012463

No Description
BIOCARE MEDICAL LLC
RALP525G
In Commercial Distribution

  • 00847627012463 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse HRP-Polymer - 00847627009388

No Description
BIOCARE MEDICAL LLC
MHRP520MM
In Commercial Distribution

  • 00847627009388 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse HRP-Polymer - 00847627009371

No Description
BIOCARE MEDICAL LLC
MHRP520L
In Commercial Distribution

  • 00847627009371 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse HRP-Polymer - 00847627009364

No Description
BIOCARE MEDICAL LLC
MHRP520H
In Commercial Distribution

  • 00847627009364 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse HRP-Polymer - 00847627009357

No Description
BIOCARE MEDICAL LLC
MHRP520G
In Commercial Distribution

  • 00847627009357 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse AP-Polymer - 00847627009340

No Description
BIOCARE MEDICAL LLC
MALP521L
In Commercial Distribution

  • 00847627009340 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Mouse AP-Polymer - 00847627009333

No Description
BIOCARE MEDICAL LLC
MALP521H
In Commercial Distribution

  • 00847627009333 ()


  • Immunohistochemistry antibody detection IVD, reagent
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