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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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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
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
The Anti-Leb reagent (Anti-LE2) is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904558
In Commercial Distribution

  • 10758750013111 ()


  • Anti-Le^b red blood cell grouping IVD, antibody
The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904549
In Commercial Distribution

  • 10758750013036 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody
The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904547
In Commercial Distribution

  • 10758750013012 ()


  • Anti-Fy^b red blood cell grouping IVD, antibody
Anti-Fyb (Anti-Duffy B)
ORTHO-CLINICAL DIAGNOSTICS, INC.
725230
In Commercial Distribution

  • 10758750004188 ()
725230

  • Anti-Fy^b red blood cell grouping IVD, antibody
Anti-Jkb (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721480
In Commercial Distribution

  • 10758750004157 ()
721480

  • Anti-Jk^b red blood cell grouping IVD, antibody
ANTI-LEB (LE2) (MURINE MONOCLONAL) BIOCLONE 2.0
ORTHO-CLINICAL DIAGNOSTICS, INC.
715380
In Commercial Distribution

  • 10758750003396 ()
715380

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