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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® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution

  • 00382903492091 ()
349209

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control
Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510205
In Commercial Distribution

  • 00858400005039 ()


  • Anti-Kp^b red blood cell grouping IVD, antibody
This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z168U
In Commercial Distribution

  • 05060242472527 ()
  • 05060242472510 ()
  • 05060242472534 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody
The Anti-Fyb reagent is for the in vitro detection and identification of human Fyb positive red blood cells by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z154U
In Commercial Distribution

  • 05060242471780 ()


  • Anti-Fy^b red blood cell grouping IVD, antibody
This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z166U
In Commercial Distribution

  • 05060242471711 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Lub (Murine Monoclonal IgG) for tube technique.
ALBA BIOSCIENCE LIMITED
Z223U
In Commercial Distribution

  • 05060242471032 ()


  • Anti-Lu^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Fyb (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z153U
Not in Commercial Distribution

  • 05060242470981 ()


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