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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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Seraclone® Anti-Jka (JK1) - 07611969951758

Blood Grouping Reagent Anti-Jka (JK1); Seraclone® Human Monoclonal (MS15); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808179100
In Commercial Distribution

  • 07611969951758 ()
808179100

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

Mercodia Lp(a) ELISA - 07350108630016

Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma.
Mercodia AB
10-1106-01
In Commercial Distribution

  • 07350108630016 ()
10-1106-01

  • Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)

ORTHOTM Sera Anti-Lea Blood Grouping Reagent - 10758750013104

The Anti-Lea reagent (Anti-LE1) is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904557
In Commercial Distribution

  • 10758750013104 ()


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

ORTHOTM Sera Anti-Jka - 10758750013029

The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904548
In Commercial Distribution

  • 10758750013029 ()


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

ORTHOTM Sera Anti-Fya - 10758750013005

The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904546
In Commercial Distribution

  • 10758750013005 ()


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

BIOCLONE - 10758750004140

Anti-Jka (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721380
In Commercial Distribution

  • 10758750004140 ()
721380

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

Quidel Molecular - 30014613311065

QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control

CEDIA Cyclosporine PLUS High Range Calibrators (450/2000) - 00884883001299

No Description
Microgenics Corporation
100012
In Commercial Distribution

  • 00884883001299 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Anti-Lea (LE1) - 23661562105414

Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
DIAGAST
210541
In Commercial Distribution

  • 23661562105414 ()
210541

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

Anti-Jka (JK1) - 23661562105346

Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

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