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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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ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
Diagnostic Automation, Inc.
DACD330-50
In Commercial Distribution

  • 00894175000619 ()

  • 50 Tests/Kit
330-50

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z164U
In Commercial Distribution

  • 05060242472497 ()
  • 05060242472480 ()
  • 05060242472503 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z162U
In Commercial Distribution

  • 05060242471704 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.
ALBA BIOSCIENCE LIMITED
Z152U
In Commercial Distribution

  • 05060242471698 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z231U
In Commercial Distribution

  • 05060242471056 ()


  • Anti-Wr^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z212U
In Commercial Distribution

  • 05060242471025 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z151U
Not in Commercial Distribution

  • 05060242470974 ()


  • Anti-Fy^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
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