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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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IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgG - 00630414963822

CMV IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381289
In Commercial Distribution

  • 00630414963822 ()
LKCV1

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems RUB Rubella Quantitative IgG - 00630414962061

Rubella IgG Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381305
In Commercial Distribution

  • 00630414962061 ()
L2KRUB6

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems RUB Rubella Quantitative IgG - 00630414962054

Rubella IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381338
In Commercial Distribution

  • 00630414962054 ()
L2KRUB2

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems CVG CMV IgG - 00630414961231

CMV IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381309
In Commercial Distribution

  • 00630414961231 ()
L2KCVG2

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

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

Tissue-Tek Genie® - 00615233008930

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8384-C010
In Commercial Distribution

  • 00615233008930 ()
8384-C010

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Adenovirus IgG ELISA - 00404847434460

The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum. This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3446
Not in Commercial Distribution

  • 00404847434460 ()
EIA-3446

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

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

Mumps IgG IFA Slide Only Kit - G5229032011

For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903201
In Commercial Distribution

  • G5229032011 ()


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

Mumps IgG IFA 96 Test - G5229032001

For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903200
In Commercial Distribution

  • G5229032001 ()


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