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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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S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Radiometer Medical ApS
944-136
In Commercial Distribution

  • 15700699441369 ()
  • 05700699441362 ()
944-136

  • Wash/cleaning solution IVD, automated/semi-automated system
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
Radiometer Medical ApS
944-135
In Commercial Distribution

  • 15700699441352 ()
  • 05700699441355 ()
944-135

  • Multiple blood gas analyte IVD, calibrator
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
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
Radiometer Medical ApS
944-133
In Commercial Distribution

  • 15700699441338 ()
  • 05700699441331 ()
944-133

  • Multiple blood gas analyte IVD, calibrator
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang C 70ML Frozen Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
C108-70ML
In Commercial Distribution

  • 00857515006122 ()

  • Total Volume: 70 Milliliter
C108

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
605to
In Commercial Distribution

  • 00859110005944 ()

  • 2 tests
605to

  • Glycated haemoglobin (HbA1c) IVD, control
Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
605
In Commercial Distribution

  • 00859110005937 ()

  • 2 tests
605

  • Glycated haemoglobin (HbA1c) IVD, control
Validate SP3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
603ro
In Commercial Distribution

  • 00859110005920 ()

  • 2 tests
603ro

  • Multiple clinical chemistry protein IVD, control
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