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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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EliA IgA Calibrator Strip
Phadia AB
83-0003-31
In Commercial Distribution

  • 07333066013763 ()
  • 07333066012834 ()
83-0003-31

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Conjugate
Phadia AB
83-0002-81
In Commercial Distribution

  • 07333066013695 ()
  • 07333066012780 ()
  • 07333066013718 ()
83-0002-81

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Curve Control
Phadia AB
83-0002-71
In Commercial Distribution

  • 07333066013688 ()
  • 07333066012773 ()
83-0002-71

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgA Conjugate
Phadia AB
34-2328-11
In Commercial Distribution

  • 07333066000510 ()
  • 07333066012230 ()
34-2328-11

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
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)
Contains one vial of each Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0) to form a complete calibration curve for the ImmunoCAP Specific IgA method.
Phadia AB
10-9304-01
In Commercial Distribution

  • 07333066019550 ()
10-9304-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Calibrator Well
Phadia AB
DECC055160
In Commercial Distribution

  • 07333066010694 ()
  • 07333066014654 ()
DECC055160

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369151 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369144 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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