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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
AMERICAN NATIONAL RED CROSS
510205
In Commercial Distribution

  • 00858400005039 ()


  • Anti-Kp^b red blood cell grouping IVD, antibody
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
This monoclonal reagent is used for the detection of the Jkb antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004813
In Commercial Distribution

  • 10888234002192 ()
0004813

  • Anti-Jk^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Leb antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004864
In Commercial Distribution

  • 10888234001898 ()
0004864

  • Anti-Le^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Jkb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007604
In Commercial Distribution

  • 10888234000822 ()
0007604

  • Anti-Jk^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Fyb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007594
In Commercial Distribution

  • 10888234000808 ()
0007594

  • Anti-Fy^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Kpb antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007550
In Commercial Distribution

  • 10888234000785 ()
0007550

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

  • 10758750001231 ()
  • 20758750001238 ()
6801430

  • Hepatitis B virus core total antibody IVD, control
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
No Description
Roche Diagnostics GmbH
04927931162
In Commercial Distribution

  • 07613336183199 ()
04927931162

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
09367039190
In Commercial Distribution

  • 07613336183021 ()
09367039190

  • Hepatitis B virus core total antibody IVD, control
Blood Grouping Reagent Anti-Jkb (JK2); Seraclone® Human Monoclonal (MS8); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808184100
In Commercial Distribution

  • 07611969951796 ()
808184100

  • Anti-Jk^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is designed to determine the presence of the blood group antigen Leb (LE2) on the surface of human red blood cells by manual tube method.
DIAGAST
210542
In Commercial Distribution

  • 23661562105421 ()
210542

  • Anti-Le^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method.
DIAGAST
210535
In Commercial Distribution

  • 23661562105353 ()
210535

  • Anti-Jk^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) (SpA264LBg1) - This reagent is designed to determine the presence of the blood group antigen Fyb (FY2) on the surface of human red blood cells by manual tube method.
DIAGAST
210532
In Commercial Distribution

  • 23661562105322 ()
210532

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