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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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Trinity Biotech - 05391516749114

T. pallidum Marblot Strip, 20 each pack
MARDX DIAGNOSTICS, INC.
40-5018
In Commercial Distribution

  • 05391516749114 ()
40-5018

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748872

FITC Parasite IgG Conjugate (Rodent), 4.0 mL
MARDX DIAGNOSTICS, INC.
20-90215
In Commercial Distribution

  • 05391516748872 ()
20-90215

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, reagent

Trinity Biotech - 05391516748704

T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests
MARDX DIAGNOSTICS, INC.
40-5020G
In Commercial Distribution

  • 05391516748704 ()
40-5020G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

AtheNA Multi-Lyte® T. pallidum IgG Plus Test System - 00845533000116

The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
A76101G
In Commercial Distribution

  • 00845533000116 ()
A76101G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ImmunoFA Toxoplasma Slides - 00613745012070

For use with ImmunoFA Toxoplasma kits
Genbio
800-1207
In Commercial Distribution

  • 00613745012070 ()

  • 100 slides, 10 tests per slide
1207

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Toxoplasma IgG Negative Control - 00613745012032

Negative control for use with ImmunoFA Toxoplasma kits.
Genbio
800-1203
In Commercial Distribution

  • 00613745012032 ()

  • 1.0 mL
1203

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Toxoplasma Slides - 00613745012018

Toxoplasma Slides for use with ImmunoFA Toxoplasma kits
Genbio
800-1201
In Commercial Distribution

  • 00613745012018 ()

  • 10 slides, 10 tests each slide
1201

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA Mounting Fluid - 00613745010250

Mounting fluid for use with ImmunoFA kits.
Genbio
800-1025
In Commercial Distribution

  • 00613745010250 ()

  • 5 mL
1025

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA 10x PBS - 00613745010069

10-fold concentrate of 0.01M PBS
Genbio
800-1006
In Commercial Distribution

  • 00613745010069 ()

  • 250 mL
1006

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

ImmunoFA 10x PBS - 00613745010052

10-fold concentrate of 0.01M PBS
Genbio
800-1005
In Commercial Distribution

  • 00613745010052 ()

  • 50 mL
1005

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent

Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System - B110HS240120

No Description
Bion Enterprises, Ltd.
HS2-4012
In Commercial Distribution

  • B110HS240120 ()
HS2-4012

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System - B110HS130120

No Description
Bion Enterprises, Ltd.
HS1-3012
In Commercial Distribution

  • B110HS130120 ()
HS1-3012

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Atellica CH IgM_2 - 00630414595627

Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097620
In Commercial Distribution

  • 00630414595627 ()
11097620

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Atellica CH IgA_2 - 00630414595610

Immunoglobulin A (IgA_2) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097619
In Commercial Distribution

  • 00630414595610 ()
11097619

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGA_2 Reagents - 00630414513133

IgA - ADVIA Chem. - RGT - 5x75 tests
Siemens Healthcare Diagnostics Inc.
10309033
In Commercial Distribution

  • 00630414513133 ()
2194102

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGM_2 Reagents - 00630414513126

IgM - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309032
In Commercial Distribution

  • 00630414513126 ()
2193483

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N Latex IgM - 00630414285023

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873688
In Commercial Distribution

  • 00630414285023 ()
OQAC15

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Optilite IgA CSF Kit - 05051700020190

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.OPT.A
In Commercial Distribution

  • 05051700020190 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgM CSF Kit - 05051700020183

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.OPT.A
In Commercial Distribution

  • 05051700020183 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Optilite IgA Kit - 05051700017701

No Description
THE BINDING SITE GROUP LIMITED
NK010.OPT.A
In Commercial Distribution

  • 05051700017701 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgA2 Kit - 05051700017664

No Description
THE BINDING SITE GROUP LIMITED
LK088.OPT.A
In Commercial Distribution

  • 05051700017664 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgA1 Kit - 05051700017657

No Description
THE BINDING SITE GROUP LIMITED
NK087.OPT.A
In Commercial Distribution

  • 05051700017657 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgM Kit - 05051700017565

No Description
THE BINDING SITE GROUP LIMITED
NK012.OPT.A
In Commercial Distribution

  • 05051700017565 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Human IgA kit for use on SPAPLUS- Bulk Kit - 05051700016742

No Description
THE BINDING SITE GROUP LIMITED
NK010.10S
In Commercial Distribution

  • 05051700016742 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Human IgM CSF Kit for use on SPAPLUS - 05051700016179

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.S
Not in Commercial Distribution

  • 05051700016179 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Human IgA CSF Kit for use on SPAPLUS - 05051700016162

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.S
Not in Commercial Distribution

  • 05051700016162 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA2 Kit for use on SPAPLUS - 05051700012324

No Description
THE BINDING SITE GROUP LIMITED
LK088.S
Not in Commercial Distribution

  • 05051700012324 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA1 Kit SPAplus - 05051700012317

No Description
THE BINDING SITE GROUP LIMITED
NK087.S
Not in Commercial Distribution

  • 05051700012317 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA Liquid Reagent Kit for use on SPAPLUS - 05051700012232

No Description
THE BINDING SITE GROUP LIMITED
NK010.S
Not in Commercial Distribution

  • 05051700012232 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Human IgA1 Subclass BNII Kit - 05051700007801

No Description
THE BINDING SITE GROUP LIMITED
NK087.1T
In Commercial Distribution

  • 05051700007801 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II - 05051700006538

No Description
THE BINDING SITE GROUP LIMITED
LK088.1T
In Commercial Distribution

  • 05051700006538 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II - 05051700006095

No Description
THE BINDING SITE GROUP LIMITED
LK003.T
In Commercial Distribution

  • 05051700006095 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006830

VITROS Chemistry Products IgM Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801734
In Commercial Distribution

  • 10758750006830 ()
  • 20758750006837 ()
6801734

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006816

VITROS Chemistry Products IgA Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801732
In Commercial Distribution

  • 10758750006816 ()
  • 20758750006813 ()
6801732

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

N Diluent - 00842768030239

Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD

N Reaction Buffer - 00842768014246

Reaction medium for immunochemical determination with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446455
In Commercial Distribution

  • 00842768014246 ()
OUMS65

  • Multiple clinical chemistry protein IVD, reagent

N Supplementary Reagent/Precipitation - 00842768011443

Supplementary reagent for multiple protein assays on Siemens systems
Siemens Healthcare Diagnostics Products GmbH
10446458
In Commercial Distribution

  • 00842768011443 ()
OUMU15

  • Buffered isotonic saline reagent IVD

N Diluent - 00842768011436

Solution for preparing dilutions for immunochemical determinations with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446457
In Commercial Distribution

  • 00842768011436 ()
OUMT65

  • Buffered sample diluent IVD

N Antiserum to Human Apolipoprotein A-I - 00842768011269

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011252

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
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