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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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Quidel Molecular - 30014613311164

QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

LIAISON® XL MUREX Anti-HBs - 08056771103442

No Description
DIASORIN SPA
318220
In Commercial Distribution

  • 08056771103442 ()


  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

LIAISON XL MUREX Anti-HBe - 08056771103428

No Description
DIASORIN SPA
318160
In Commercial Distribution

  • 18056771103425 ()
  • 08056771103428 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

LIAISON® XL MUREX Control Anti-HBc - 08056771103374

No Description
DIASORIN SPA
318131
In Commercial Distribution

  • 08056771103374 ()
  • 28056771103378 ()


  • Hepatitis B virus core total antibody IVD, control

ORTHOTM Sera Anti-Leb Blood Grouping Reagent - 10758750013111

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

ORTHOTM Sera Anti-Jkb - 10758750013036

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

ORTHOTM Sera Anti-Fyb - 10758750013012

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

ORTHO - 10758750004188

Anti-Fyb (Anti-Duffy B)
ORTHO-CLINICAL DIAGNOSTICS, INC.
725230
In Commercial Distribution

  • 10758750004188 ()
725230

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

BIOCLONE - 10758750004157

Anti-Jkb (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721480
In Commercial Distribution

  • 10758750004157 ()
721480

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

BIOCLONE - 10758750003396

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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