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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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Anti-Adenovirus IFA (IgG) - 04049016059387

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1003 G
Not in Commercial Distribution

  • 04049016059387 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IMMULITE Systems Rubella Quantitative IgG CVM - 00630414973784

Rubella Quantitative IgG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388114
In Commercial Distribution

  • 00630414973784 ()
LRUBCVM

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

Alinity - 00380740180973

Alinity i CMV IgG Controls
Abbott Ireland Diagnostics
07P4212
In Commercial Distribution

  • 00380740180973 ()
07P4212

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

ImmunoCAP Specific IgG Conjugate 50 - 07333066019765

ImmunoCAP Specific IgG Conjugate 50
Phadia AB
34-2271-71
In Commercial Distribution

  • 07333066000770 ()
  • 07333066019765 ()
  • 07333066000190 ()
34-2271-71

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

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)

ImmunoCAP Specific IgG Conjugate - 07333066019826

ImmunoCAP Specific IgG Conjugate
Phadia AB
34-2294-41
In Commercial Distribution

  • 07333066000503 ()
  • 07333066019826 ()
34-2294-41

  • 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)

Tissue-Tek Genie® - 00615233008947

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8384-M250
In Commercial Distribution

  • 00615233008947 ()
8384-M250

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
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