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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
995-60701
Not in Commercial Distribution

  • 00856626006120 ()
995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
Not in Commercial Distribution

  • 00856626006113 ()
995-40801

  • Total complement activity (CH50) 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
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
APPLIED BIOCODE, INC.
01
In Commercial Distribution

  • 00851034007073 ()
63-R0001

  • Multiple-type respiratory pathogen nucleic acid IVD, control
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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
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