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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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ZYMUTEST HIA IgG - 03663537018763

No Description
HYPHEN BIOMED
RK040A
In Commercial Distribution

  • 03663537018763 ()
RK040A

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

PreciControl Rubella IgG - 04015630939268

No Description
Roche Diagnostics GmbH
4618807160
In Commercial Distribution

  • 04015630939268 ()
4618807160

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

PreciControl CMV IgG - 04015630934539

No Description
Roche Diagnostics GmbH
4784600160
In Commercial Distribution

  • 04015630934539 ()
4784600160

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

ImmunoCAP Specific IgG Curve Controls - 07333066019581

Contains three vials of each Specific IgG Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgG method.
Phadia AB
10-9333-01
In Commercial Distribution

  • 07333066019581 ()
10-9333-01

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

ImmunoCAP Specific IgG Calibrators - 07333066019567

Contains one vial of each Specific IgG Calibrator (Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0, Cal-2.0) to form a complete calibration curve for the ImmunoCAP Specific IgG method.
Phadia AB
10-9305-01
In Commercial Distribution

  • 07333066019567 ()
10-9305-01

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

EliA IgG Calibrator Well - 07333066014609

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 - 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)

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)
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