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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® 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

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

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

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

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

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

Alinity - 00380740181109

Alinity i CMV IgG Reagent Kit (1000T)
Abbott Ireland Diagnostics
07P4233
In Commercial Distribution

  • 00380740181109 ()
07P4233

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

Alinity - 00380740181093

Alinity i CMV IgG Reagent Kit (200T)
Abbott Ireland Diagnostics
07P4224
In Commercial Distribution

  • 00380740181093 ()
07P4224

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

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)

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683112044

No Description
CELL MARQUE CORPORATION
367M-15
In Commercial Distribution

  • 00841683112044 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683112020

No Description
CELL MARQUE CORPORATION
367M-16
In Commercial Distribution

  • 00841683112020 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody - 00841683112006

No Description
CELL MARQUE CORPORATION
367R-14
In Commercial Distribution

  • 00841683112006 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody - 00841683111986

No Description
CELL MARQUE CORPORATION
367R-18
In Commercial Distribution

  • 00841683111986 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683100195

No Description
CELL MARQUE CORPORATION
760-2653
In Commercial Distribution

  • 00841683100195 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683121640

No Description
CELL MARQUE CORPORATION
367M-17
In Commercial Distribution

  • 00841683121640 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683112051

No Description
CELL MARQUE CORPORATION
367M-18
In Commercial Distribution

  • 00841683112051 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683112037

No Description
CELL MARQUE CORPORATION
367M-14
In Commercial Distribution

  • 00841683112037 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody - 00841683112013

No Description
CELL MARQUE CORPORATION
367R-16
In Commercial Distribution

  • 00841683112013 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody - 00841683111993

No Description
CELL MARQUE CORPORATION
367R-15
In Commercial Distribution

  • 00841683111993 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody - 00841683111979

No Description
CELL MARQUE CORPORATION
367R-17
In Commercial Distribution

  • 00841683111979 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (MRQ-44) Mouse Monoclonal Antibody - 00841683101307

No Description
CELL MARQUE CORPORATION
760-4614
In Commercial Distribution

  • 00841683101307 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Cathepsin K (3F9) Mouse Monoclonal Antibody - 00841683141211

No Description
CELL MARQUE CORPORATION
402M-18
In Commercial Distribution

  • 00841683141211 ()


  • Cathepsin IVD, antibody

Cathepsin K (3F9) Mouse Monoclonal Antibody - 00841683141204

No Description
CELL MARQUE CORPORATION
402M-17
In Commercial Distribution

  • 00841683141204 ()


  • Cathepsin IVD, antibody

Cathepsin K (3F9) Mouse Monoclonal Antibody - 00841683141198

No Description
CELL MARQUE CORPORATION
402M-16
In Commercial Distribution

  • 00841683141198 ()


  • Cathepsin IVD, antibody

Cathepsin K (3F9) Mouse Monoclonal Antibody - 00841683141181

No Description
CELL MARQUE CORPORATION
402M-15
In Commercial Distribution

  • 00841683141181 ()


  • Cathepsin IVD, antibody

Cathepsin K (3F9) Mouse Monoclonal Antibody - 00841683141174

No Description
CELL MARQUE CORPORATION
402M-14
In Commercial Distribution

  • 00841683141174 ()


  • Cathepsin IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683132004

No Description
CELL MARQUE CORPORATION
269A-18
In Commercial Distribution

  • 00841683132004 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683131991

No Description
CELL MARQUE CORPORATION
269A-17
In Commercial Distribution

  • 00841683131991 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683131984

No Description
CELL MARQUE CORPORATION
269A-16
In Commercial Distribution

  • 00841683131984 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683131977

No Description
CELL MARQUE CORPORATION
269A-15
In Commercial Distribution

  • 00841683131977 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG Rabbit Polyclonal Antibody - 00841683131960

No Description
CELL MARQUE CORPORATION
269A-14
In Commercial Distribution

  • 00841683131960 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

VITROS - 10758750004997

VITROS Immunodiagnostic Products Rubella IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
8536195
In Commercial Distribution

  • 10758750004997 ()
8536195

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

VITROS - 10758750004546

VITROS Immunodiagnostic Products Rubella IgG Calibrators
ORTHO CLINICAL DIAGNOSTICS
8209074
In Commercial Distribution

  • 10758750004546 ()
8209074

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

BioPlex 2200 - 03610520653005

BioPlex 2200 Syphilis Total & RPR Control Lot Data
BIO-RAD LABORATORIES, INC.
12000654
In Commercial Distribution

  • 03610520653005 ()

  • 1 Each
12000654

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

BioPlex 2200 - 03610520652794

BioPlex 2200 Syphilis Total & RPR Control Set
BIO-RAD LABORATORIES, INC.
12000653
In Commercial Distribution

  • 03610520652794 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
12000653

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

LIAISON® H. pylori IgG Control Set - 08056771602051

No Description
Diasorin Inc.
318981
In Commercial Distribution

  • 08056771602051 ()


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

LIAISON® VCA IgG Serum Control Set - 08056771601771

No Description
DIASORIN SPA
310512
Not in Commercial Distribution

  • 08056771601771 ()


  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control Borrelia burgdorferi - 08056771600279

No Description
Diasorin Inc.
310871
In Commercial Distribution

  • 08056771600279 ()


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