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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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Panther Fusion® GBS Controls Kit.
Hologic, Inc.
KIT, GBS CONTROLS, FUSION, IVD
In Commercial Distribution

  • 15420045510906 ()
PRD-04485

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
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
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510205
In Commercial Distribution

  • 00858400005039 ()


  • Anti-Kp^b red blood cell grouping IVD, antibody
Alinity s Anti-HBc Release Control Kit
Abbott GmbH
06P0624
In Commercial Distribution

  • 00380740167479 ()
06P0624

  • Hepatitis B virus core total antibody IVD, control
Alinity s Anti-HBc Assay Control Kit
Abbott GmbH
06P0620
In Commercial Distribution

  • 00380740167462 ()
06P0620

  • Hepatitis B virus core total antibody IVD, control
Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004818
In Commercial Distribution

  • 10888234002383 ()
0004818

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