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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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Mouse IgG1 Biotin Conjugate - 10190302009249

No Description
LIFE TECHNOLOGIES CORPORATION
MG115
In Commercial Distribution

  • 10190302009249 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 PE-Cy®7 Conjugate - 10190302009232

No Description
LIFE TECHNOLOGIES CORPORATION
MG112
In Commercial Distribution

  • 10190302009232 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 TRI-COLOR® Conjugate - 10190302009225

No Description
LIFE TECHNOLOGIES CORPORATION
MG106
In Commercial Distribution

  • 10190302009225 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 APC Conjugate - 10190302009218

No Description
LIFE TECHNOLOGIES CORPORATION
MG105
In Commercial Distribution

  • 10190302009218 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 R-PE Conjugate - 10190302009201

No Description
LIFE TECHNOLOGIES CORPORATION
MG104
In Commercial Distribution

  • 10190302009201 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 FITC Conjugate - 10190302009195

No Description
LIFE TECHNOLOGIES CORPORATION
MG101
In Commercial Distribution

  • 10190302009195 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Purified Antibody - 10190302009188

No Description
LIFE TECHNOLOGIES CORPORATION
MG100
In Commercial Distribution

  • 10190302009188 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

ImmunoDOT Borrelia Positive Control - 00613745039053

This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
Genbio
800-3905
In Commercial Distribution

  • 00613745039053 ()

  • 0.1 mL
3905

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

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)

BioPlex 2200 - 00847865000284

Syphilis IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6631440
In Commercial Distribution

  • 00847865000284 ()

  • 1 Each
6631440

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 - 00847865000277

Syphilis IgG Control Set
BIO-RAD LABORATORIES, INC.
6631430
In Commercial Distribution

  • 00847865000277 ()

  • Total Volume: 1.5 Milliliter
  • 6 Vials
6631430

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

VIROTROL - 00847661002765

VIROTROL Lyme (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00132
In Commercial Distribution

  • 00847661002765 ()
00132

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

PyloriTrol - 00847661002673

PyloriTrol (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00121
In Commercial Distribution

  • 00847661002673 ()
00121

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

Atellica IM CMV IgG - 00630414246635

CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

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

Atellica IM Rub G - 00630414600529

Rubella IgG (Rub G) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995670
In Commercial Distribution

  • 00630414600529 ()
10995670

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

ADVIA Centaur CMV IgG - 00630414588872

CMV IgG ADVIA Centaur - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10632820
In Commercial Distribution

  • 00630414588872 ()
10632820

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

ADVIA Centaur® Rub G - 00630414201412

Rubella IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310283
In Commercial Distribution

  • 00630414201412 ()
117710

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

IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG - 00630414964614

Rubella IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381292
In Commercial Distribution

  • 00630414964614 ()
LKRUB1

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

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
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