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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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CSA Pretreatment - CENTAUR - CONS - 2x26mL
Siemens Healthcare Diagnostics Inc.
10335453
In Commercial Distribution

  • 00630414524474 ()
  • 00630414003689 ()
4567127

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8487-C010
In Commercial Distribution

  • 00615233010131 ()
8487-C010

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody
anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8487-M100
In Commercial Distribution

  • 00615233010124 ()
8487-M100

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z164U
In Commercial Distribution

  • 05060242472497 ()
  • 05060242472480 ()
  • 05060242472503 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z162U
In Commercial Distribution

  • 05060242471704 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.
ALBA BIOSCIENCE LIMITED
Z152U
In Commercial Distribution

  • 05060242471698 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z231U
In Commercial Distribution

  • 05060242471056 ()


  • Anti-Wr^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z212U
In Commercial Distribution

  • 05060242471025 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z151U
Not in Commercial Distribution

  • 05060242470974 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
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