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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® Systems HPG CONTROL H.pylori IgG - 00630414989907

H.Pylori - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469596
In Commercial Distribution

  • 00630414989907 ()
LHPGCM

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

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

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

IMMULITE® Systems HPG Calibration Verification Material H. pylori IgG - 00630414973678

H. Pylori CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387993
In Commercial Distribution

  • 00630414973678 ()
LHPGCVM

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

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
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