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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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MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.
MORE DIAGNOSTICS INC
202
In Commercial Distribution

  • 00856743007055 ()
202

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510215
In Commercial Distribution

  • 00858400005077 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510204
In Commercial Distribution

  • 00858400005022 ()


  • Anti-Kp^a red blood cell grouping IVD, antibody
Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206631
In Commercial Distribution

  • 05391516748780 ()
1206631

  • Clostridium difficile toxin A/B antigen IVD, control
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
Clostridium difficile Toxin Control, 1.0 mL
MARDX DIAGNOSTICS, INC.
B1029-70A
In Commercial Distribution

  • 05391516747936 ()
B1029-70A

  • Clostridium difficile toxin A/B antigen IVD, control
Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.
IMMUCOR, INC.
10 mL size vial / 5mL fill volume
In Commercial Distribution

  • 10888234002239 ()
0066430

  • Anti-Fy^a red blood cell grouping IVD, antibody
This monoclonal reagent is used for the detection of the Fya antigen (of the Duffy blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004816
In Commercial Distribution

  • 10888234002222 ()
0004816

  • Anti-Fy^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004812
In Commercial Distribution

  • 10888234002185 ()
0004812

  • Anti-Jk^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Lea antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004861
In Commercial Distribution

  • 10888234001881 ()
0004861

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