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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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STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - B126KR60100

A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR6010
In Commercial Distribution

  • B126KR60100 ()
KR6010

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay

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 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®/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® 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

IMMULITE® 2000 Systems RUB Rubella Quantitative IgG - 00630414962054

Rubella IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381338
In Commercial Distribution

  • 00630414962054 ()
L2KRUB2

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

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 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

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
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