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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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Alinity - 00380740153922

Alinity c Immunoglobulin G Reagent Kit 360 Tests
Abbott GmbH
09P6220
In Commercial Distribution

  • 00380740153922 ()
09P6220

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740019761

Immunoglobulin G
ABBOTT LABORATORIES
9D99-21
In Commercial Distribution

  • 00380740019761 ()
09D9921

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740011178

ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control

VIDAS® RUB IgG - 03573026138585

VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum.
BIOMERIEUX SA
30226
In Commercial Distribution

  • 03573026138585 ()


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

VIDAS® CMV IgG - 03573026156831

VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma.
BIOMERIEUX SA
30204-01
In Commercial Distribution

  • 03573026156831 ()


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

VIDAS® Measles IgG - 03573026064532

VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.
BIOMERIEUX SA
30219
In Commercial Distribution

  • 03573026064532 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

VIDAS® Mumps IgG - 03573026064525

VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus
BIOMERIEUX SA
30218
In Commercial Distribution

  • 03573026064525 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

BioPlex 2200 - 03610520506417

BioPlex 2200 Lyme Total Calibrator CD
BIO-RAD LABORATORIES, INC.
12000878
In Commercial Distribution

  • 03610520506417 ()

  • 1 Each
12000878

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator

BioPlex 2200 - 03610520506400

BioPlex 2200 Lyme Total Calibrator Set
BIO-RAD LABORATORIES, INC.
12000877
In Commercial Distribution

  • 03610520506400 ()

  • 3 Vials
  • Total Volume: 0.5 Milliliter
12000877

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator

Platelia - 03610520002490

Platelia Aspergillus IgG - negative and positive controls
BIO-RAD
62786
In Commercial Distribution

  • 03610520002490 ()

  • 48 tests
62786

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, control

LIAISON® MUREX Control HCV Ab - 08056771500227

No Description
DIASORIN S.P.A.
318241
In Commercial Distribution

  • 08056771500227 ()
  • 28056771500221 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, control

Biotrin Parvovirus B19 IgG EIA - 08056771103343

No Description
DIASORIN SPA
V519IGUS
In Commercial Distribution



  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS MUMPS IgG - 08033891322458

No Description
DIESSE DIAGNOSTICA SENESE SPA
81075
In Commercial Distribution

  • 08033891322458 ()
81075

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS MEASLES IgG - 08033891322434

No Description
DIESSE DIAGNOSTICA SENESE SPA
81072
In Commercial Distribution

  • 08033891322434 ()
81072

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ - 00894175000053

AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
Diagnostic Automation, Inc.
DACD 1201-2
In Commercial Distribution

  • 00894175000053 ()

  • 96 Tests
1201-2

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

AccuDiag ™ - 00894175000039

AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
Diagnostic Automation, Inc.
DACD 1301-2
In Commercial Distribution

  • 00894175000039 ()

  • 96 TESTS
1301-2

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

CMV IgG ELISA - 00840239027979

The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
DRG International Inc
EIA-2797
In Commercial Distribution

  • 00840239027979 ()
EIA-2797

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

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055167

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1010 G
Not in Commercial Distribution

  • 04049016055167 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055143

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1003 G
Not in Commercial Distribution

  • 04049016055143 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Mumps Virus ELISA (IgG) - 04049016028017

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601 G
In Commercial Distribution

  • 04049016028017 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Measles Virus ELISA (IgG) - 04049016027973

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2610-9601 G
In Commercial Distribution

  • 04049016027973 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Mumps Virus AT ELISA (IgG) - 04049016083283

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Avidity: Anti-Measles Virus ELISA (IgG) - 04049016083276

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2610-9601-1 G
Not in Commercial Distribution

  • 04049016083276 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055174

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-2005 G
Not in Commercial Distribution

  • 04049016055174 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055150

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1005 G
Not in Commercial Distribution

  • 04049016055150 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Alere Rubella-plus® - 10859035006245

No Description
ALERE NORTH AMERICA, LLC
84R2
In Commercial Distribution

  • 10859035006245 ()
  • 00859035006248 ()


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

Elecsys Rubella IgG - 04015630940240

No Description
Roche Diagnostics GmbH
07027770190
In Commercial Distribution

  • 04015630940240 ()
07027770190

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

Elecsys Rubella IgG Immunoassay - 04015630939251

No Description
Roche Diagnostics GmbH
4618793160
In Commercial Distribution

  • 04015630939251 ()
4618793160

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

CMV IgG ELISA - 04048474027976

The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2797
In Commercial Distribution

  • 04048474027976 ()
EIA-2797

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

Dimension® Flex® reagent cartridge IGG - 00842768005701

Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
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