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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 IgG Conjugate 200 - 07333066012827

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 Conjugate 50 - 07333066012810

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)

EliA IgG Curve Control Strip - 07333066012803

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 - 07333066012797

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 - 07333066012704

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 - 07333066012629

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 Specific IgG Curve Control Strip - 07333066011615

ImmunoCAP Specific IgG Curve Control Strip
Phadia AB
34-2273-31
In Commercial Distribution

  • 07333066000305 ()
  • 07333066011615 ()
34-2273-31

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

ImmunoCAP Specific IgG Calibrator Strip - 07333066011585

ImmunoCAP Specific IgG Calibrator Strip
Phadia AB
34-2272-71
In Commercial Distribution

  • 07333066000237 ()
  • 07333066011585 ()
34-2272-71

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

Trinity Biotech - 05391516748810

Uni-Gold™ S. pneumoniae, 20 Tests
MARDX DIAGNOSTICS, INC.
1204420
In Commercial Distribution

  • 05391516748810 ()
1204420

  • Streptococcus pneumoniae immunoglobulin G (IgG) antibody IVD, kit, multiplex

Pseudomonas-CF-IgG standard control serum - 05713106609002

Human-antisera, Pseudomonas-CF-IgG
Ssi Diagnostica A/S
60900
Not in Commercial Distribution

  • 05713106609002 ()
60900

  • Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, control
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