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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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ARCHITECT Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
This reagent is used for the detection of the Di(a) antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007620
In Commercial Distribution

  • 10888234000839 ()
0007620

  • Anti-Di^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.
0007601
In Commercial Distribution

  • 10888234000815 ()
0007601

  • Anti-Jk^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Fya antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007591
In Commercial Distribution

  • 10888234000792 ()
0007591

  • Anti-Fy^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Kpa antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007540
In Commercial Distribution

  • 10888234000778 ()
0007540

  • Anti-Kp^a red blood cell grouping IVD, antibody
Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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