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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.
03599779190
In Commercial Distribution

  • 00875197002102 ()
03599779190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
04584252190
In Commercial Distribution

  • 00875197001662 ()
04584252190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197001099 ()
03322114018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197001068 ()
03302563018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrators Kit
In Commercial Distribution

  • 00859882007351 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Controls Kit
In Commercial Distribution

  • 00859882007344 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Calibrators Kit
In Commercial Distribution

  • 00859882007337 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Controls Kit
In Commercial Distribution

  • 00859882007320 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HBV Discriminatory Probe Reagent Kit
In Commercial Distribution

  • 00859882007313 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HCV Discriminatory Probe Reagent Kit
In Commercial Distribution

  • 00859882007306 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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