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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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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
ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
ABBOTT LABORATORIES
1L75-55
In Commercial Distribution

  • 00380740001322 ()
01L7555

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
ARCHITECT Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Syva® Emit® Cyclosporine Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10445378
In Commercial Distribution

  • 00842768001482 ()
  • 00630414010533 ()
6R719UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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