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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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BD Simultest™ IMK-Lymphocyte
Becton, Dickinson And Company
340182
In Commercial Distribution

  • 00382903401826 ()
340182

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD FACSCount Reagent Kit 50 Tests IVD
Becton, Dickinson And Company
340167
In Commercial Distribution

  • 00382903401673 ()
340167

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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
No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control
Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
3x10 ml
In Commercial Distribution

  • 07640137340308 ()
213632

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
2x10 ml
In Commercial Distribution

  • 07640137340292 ()
213635

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
3x10 ml
In Commercial Distribution

  • 07640137340322 ()
213662

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
2x10 ml
In Commercial Distribution

  • 07640137340315 ()
213660

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
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