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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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No Description
THE BINDING SITE GROUP LIMITED
LK001.TB
Not in Commercial Distribution

  • 05051700006088 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Human IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Hitachi Modular P
THE BINDING SITE GROUP LIMITED
LK001.H
In Commercial Distribution

  • 05051700006064 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK001.2TB
Not in Commercial Distribution

  • 05051700006033 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
HAVAb IgG II Controls
Abbott GmbH
06S9310
In Commercial Distribution

  • 00380740197643 ()
06S9310

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
Immunoglobulin G
Abbott GmbH
9D99-22
Not in Commercial Distribution

  • 00380740175184 ()
09D9922

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Alinity c Immunoglobulin G Reagent Kit 360 Tests
Abbott GmbH
09P6220
In Commercial Distribution

  • 00380740153922 ()
09P6220

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin G
ABBOTT LABORATORIES
9D99-21
In Commercial Distribution

  • 00380740019761 ()
09D9921

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
Alinity i CMV IgG Calibrators
Abbott Ireland Diagnostics
07P4202
In Commercial Distribution

  • 00380740180966 ()
07P4202

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator
Immunoglobulin G 388 tests
ABBOTT IRELAND
09D9924
In Commercial Distribution

  • 00380740169909 ()
09D9924

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin G 360 Tests
ABBOTT IRELAND
09P6224
In Commercial Distribution

  • 00380740169893 ()
09P6224

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Mumps IgG EIA
Bio-RAD Laboratories, Inc.
25182
In Commercial Distribution

  • 00847865010771 ()

  • 96 Tests
25182

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Measles IgG EIA
Bio-RAD Laboratories, Inc.
25181
In Commercial Distribution

  • 00847865010764 ()

  • 96 Tests
25181

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CMV IgG EIA
Bio-RAD Laboratories, Inc.
25177
In Commercial Distribution

  • 00847865010726 ()

  • 96 Tests
25177

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Rubella IgG EIA
Bio-RAD Laboratories, Inc.
25173
In Commercial Distribution

  • 00847865010689 ()

  • 96 Tests
25173

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
For the detection and titration of C. trachomatis IgG antibodies in human sera
Hemagen Diagnostics, Inc.
903001
In Commercial Distribution

  • G5229030011 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of C. trachomatis IgG antibodies in human sera.
Hemagen Diagnostics, Inc.
903000
In Commercial Distribution

  • G5229030001 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902801
In Commercial Distribution

  • G5229028011 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902800
In Commercial Distribution

  • G5229028001 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2797
In Commercial Distribution

  • 04048474027976 ()
EIA-2797

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07027770190
In Commercial Distribution

  • 04015630940240 ()
07027770190

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4618793160
In Commercial Distribution

  • 04015630939251 ()
4618793160

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN IRELAND LIMITED
V5191GUS
In Commercial Distribution

  • EBTRV519IGUS02 ()


  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
I-CTR01G
In Commercial Distribution

  • 00813545025519 ()
I-CTR01G

  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
DIASORIN S.P.A.
318241
In Commercial Distribution

  • 08056771500227 ()
  • 28056771500221 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN SPA
V519IGUS
In Commercial Distribution



  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
ALERE NORTH AMERICA, LLC
84R2
In Commercial Distribution

  • 10859035006245 ()
  • 00859035006248 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.
BIOMERIEUX SA
30219
In Commercial Distribution

  • 03573026064532 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus
BIOMERIEUX SA
30218
In Commercial Distribution

  • 03573026064525 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
Diagnostic Automation, Inc.
DACD 1201-2
In Commercial Distribution

  • 00894175000053 ()

  • 96 Tests
1201-2

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
Diagnostic Automation, Inc.
DACD 1301-2
In Commercial Distribution

  • 00894175000039 ()

  • 96 TESTS
1301-2

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® Rubella card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-171-10-01
In Commercial Distribution

  • 10743816001034 ()
BSP-171-10-01

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® Rubella card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-171-35-01
In Commercial Distribution

  • 10743816001027 ()
BSP-171-35-01

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81075
In Commercial Distribution

  • 08033891322458 ()
81075

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81072
In Commercial Distribution

  • 08033891322434 ()
81072

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma.
BIOMERIEUX SA
30204-01
In Commercial Distribution

  • 03573026156831 ()


  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum.
BIOMERIEUX SA
30226
In Commercial Distribution

  • 03573026138585 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.
Gold Standard Diagnostics Corporation
720-540
In Commercial Distribution

  • B3507205400 ()
720-540

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection.
Gold Standard Diagnostics Corporation
720-520
In Commercial Distribution

  • B3507205200 ()
720-520

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