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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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CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995549
In Commercial Distribution

  • 00630414598734 ()
  • 00842768027383 ()
10995549

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-100
In Commercial Distribution

  • 00657498001233 ()
1125-100

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-050
In Commercial Distribution

  • 00657498001226 ()
1125-050

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
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
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