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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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In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-60601
Not in Commercial Distribution

  • 00856626006205 ()
999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
Not in Commercial Distribution

  • 00856626006120 ()
995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
Not in Commercial Distribution

  • 00856626006106 ()
995-06101

  • Microalbumin IVD, calibrator
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
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
Chang C 14ML Frozen Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
C106-14ML
In Commercial Distribution

  • 00857515006115 ()

  • Total Volume: 14 Milliliter
C106

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
CHANG Medium® D with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99404-500mL
Not in Commercial Distribution

  • 00857515006030 ()

  • Total Volume: 500 Milliliter
99404

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
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
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