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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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Gold Kit 80-100 Test
DREW SCIENTIFIC, INC.
014-080
In Commercial Distribution

  • 00817274020135 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control
Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method.
Phadia AB
83-1000-01
In Commercial Distribution

  • 07333066020051 ()
83-1000-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Calibrator Well
Phadia AB
DECC055090
In Commercial Distribution

  • 07333066010649 ()
  • 07333066014609 ()
DECC055090

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Conjugate 200
Phadia AB
83-0003-21
In Commercial Distribution

  • 07333066013756 ()
  • 07333066012827 ()
83-0003-21

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Curve Control Strip
Phadia AB
83-0003-01
In Commercial Distribution

  • 07333066013732 ()
  • 07333066012803 ()
83-0003-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Calibrator Strip
Phadia AB
83-0002-91
In Commercial Distribution

  • 07333066013725 ()
  • 07333066012797 ()
83-0002-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Curve Control
Phadia AB
83-0000-91
In Commercial Distribution

  • 07333066013633 ()
  • 07333066012704 ()
83-0000-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Conjugate
Phadia AB
83-0000-11
In Commercial Distribution

  • 07333066013640 ()
  • 07333066012629 ()
  • 07333066013664 ()
83-0000-11

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP IgA/IgG Calibrator ImmunoCAP
Phadia AB
14-4424-01
In Commercial Distribution

  • 07333066003740 ()
14-4424-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Conjugate 50
Phadia AB
83-0003-11
In Commercial Distribution

  • 07333066013749 ()
  • 07333066012810 ()
83-0003-11

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
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