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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
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