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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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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 2
In Commercial Distribution

  • 00859882007528 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
0.8% Affirmagen® 3 (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719211
In Commercial Distribution

  • 10758750003914 ()
719211

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Affirmagen® (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719210
In Commercial Distribution

  • 10758750003907 ()
719210

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
0.8% Affirmagen® (Pooled Cells)
ORTHO-CLINICAL DIAGNOSTICS, INC.
719201
In Commercial Distribution

  • 10758750003877 ()
719201

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002345
In Commercial Distribution

  • 10888234000273 ()
0002345

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
This configuration of the product contains four (4) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002338
In Commercial Distribution

  • 10888234000259 ()
0002338

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
BD Leucocount Combo RBC/PLT Control Kit
BECTON, DICKINSON AND COMPANY
341003
Not in Commercial Distribution

  • 00382903410033 ()
341003

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Leucocount PLT Control Kit 25 Tests IVD
BECTON, DICKINSON AND COMPANY
341002
Not in Commercial Distribution

  • 00382903410026 ()
341002

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Leucocount RBC Control Kit 25 Tests IVD
BECTON, DICKINSON AND COMPANY
341001
Not in Commercial Distribution

  • 00382903410019 ()
341001

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD® CD3 (SK7) FITC
Becton, Dickinson And Company
340542
In Commercial Distribution

  • 00382903405428 ()
340542

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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