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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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No Description
Microgenics Corporation
10016283
In Commercial Distribution

  • 00884883011861 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Microgenics Corporation
100147
In Commercial Distribution

  • 00884883001589 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
SEKISUI DIAGNOSTICS, LLC
148
In Commercial Distribution

  • 00742860100116 ()
  • 10742860100113 ()
148

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
141-10
In Commercial Distribution

  • 00742860100109 ()
  • 10742860100106 ()
141-10

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
755250
In Commercial Distribution

  • 00742860100024 ()
  • 10742860100021 ()
755250

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
149
In Commercial Distribution

  • 00742860001499 ()
  • 10742860001472 ()
149

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
147
In Commercial Distribution

  • 00742860001475 ()
  • 10742860001472 ()
147

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
141
In Commercial Distribution

  • 00742860001413 ()
  • 10742860001410 ()
141

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.
Phadia AB
83-1013-01
In Commercial Distribution

  • 07333066020075 ()
83-1013-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgA method.
Phadia AB
10-9308-01
In Commercial Distribution

  • 07333066019574 ()
10-9308-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
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