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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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ORTHO - 10758750007462

T.CRUZI ELISA Test System 480T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901968
In Commercial Distribution

  • 10758750007462 ()
6901968

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

AccuDiag™ - 00894175000527

AccuDiag™Measles IgM ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Measles virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD 1409-1
In Commercial Distribution

  • 00894175000527 ()

  • 96 Tests
1409-1

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Alinity - 00380740193829

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740192112

SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R9010
In Commercial Distribution

  • 00380740192112 ()
06R9010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740191825

SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R8610
In Commercial Distribution

  • 00380740191825 ()
06R8610

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

N AS IgG2 - 00842768008467

Quantitative determination of IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N AS IgG1 - 00842768008450

Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N Latex IgG3 - 00842768006708

Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445972
In Commercial Distribution

  • 00842768006708 ()
OPAV03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N Latex IgG4 - 00842768006692

Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
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