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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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2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.
ALBA BIOSCIENCE LIMITED
Z421U
In Commercial Distribution

  • 05060242471155 ()


  • Group O Rh (D) negative reagent red blood cell IVD, antigen
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Positive Calibrator Kit
In Commercial Distribution

  • 00859882007696 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrator Kit
In Commercial Distribution

  • 00859882007689 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 1
In Commercial Distribution

  • 00859882007672 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 1
In Commercial Distribution

  • 00859882007665 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Discriminatory Probe Kit
In Commercial Distribution

  • 00859882007603 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
High Volume Calibrator Kit
In Commercial Distribution

  • 00859882007597 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 4
In Commercial Distribution

  • 00859882007580 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007573 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007566 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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