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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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No Description
Roche Molecular Systems, Inc.
1.0
In Commercial Distribution

  • 00875197004199 ()
05852170190

  • KRAS gene mutation IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05985579190
In Commercial Distribution

  • 00875197004137 ()
05985579190

  • BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05985536190
In Commercial Distribution

  • 00875197004120 ()
05985536190

  • Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235898190
In Commercial Distribution

  • 00875197003260 ()
05235898190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235871190
In Commercial Distribution

  • 00875197003246 ()
05235871190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235855190
In Commercial Distribution

  • 00875197003222 ()
05235855190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235839190
In Commercial Distribution

  • 00875197003208 ()
05235839190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235804190
In Commercial Distribution

  • 00875197003185 ()
05235804190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197002706 ()
05027012190

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
03577163190
In Commercial Distribution

  • 00875197002003 ()
03577163190

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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