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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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No Description
DIASORIN SPA
318220
In Commercial Distribution

  • 08056771103442 ()


  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
318160
In Commercial Distribution

  • 18056771103425 ()
  • 08056771103428 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
318131
In Commercial Distribution

  • 08056771103374 ()
  • 28056771103378 ()


  • 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
VITROS Immunodiagnostic Products Anti-HBc Controls
ORTHO CLINICAL DIAGNOSTICS
6801430
In Commercial Distribution

  • 10758750001231 ()
  • 20758750001238 ()
6801430

  • Hepatitis B virus core total antibody IVD, control
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