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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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HSV ELISA Negative Control - 10816101022080

No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control

Legionella pneumophila IgG ELISA - 00840239056450

The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5645
In Commercial Distribution

  • 00840239056450 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Legionella pneumophila IgG ELISA - 04048474056457

The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5645
In Commercial Distribution

  • 04048474056457 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Parainfluenza 1 Virus Antigen Substrate, 12 wells, For IFA Test System - B110P171120

No Description
Bion Enterprises, Ltd.
P1-7112
Not in Commercial Distribution

  • B110P171120 ()
P1-7112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent

Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies - B085K087M60

No Description
AALTO SCIENTIFIC
K087M-6
In Commercial Distribution

  • B085K087M60 ()


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

Audit MicroControls Control LQ COVID-19 Antibodies - B085K077M60

No Description
AALTO SCIENTIFIC
K077M-6
In Commercial Distribution

  • B085K077M60 ()


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

Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110CB33120

No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System - B110CB33060

No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Parainfluenza 3 Virus Antigen Substrate, 12 wells, For IFA Test System - B110P391120

No Description
Bion Enterprises, Ltd.
P3-9112
Not in Commercial Distribution

  • B110P391120 ()
P3-9112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent

Parainfluenza 2 Virus Antigen Substrate, 12 wells, For IFA Test System - B110P281120

No Description
Bion Enterprises, Ltd.
P2-8112
Not in Commercial Distribution

  • B110P281120 ()
P2-8112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent

IMMY - 00816387020797

ID Candida Antibody System
Immuno-Mycologics, Inc.
CA1001
In Commercial Distribution

  • 00816387020797 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

IMMY - 00816387020230

Candida ID Positive Control
Immuno-Mycologics, Inc.
C60110
In Commercial Distribution

  • 00816387020230 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

IMMY - 00816387020223

Candida ID Antigen
Immuno-Mycologics, Inc.
C50110
In Commercial Distribution

  • 00816387020223 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

EliA SARS-CoV-2-Sp1 IgG Well - 07333066021287

EliA SARS-CoV-2-Sp1 IgG Well
Phadia AB
DECC066630
In Commercial Distribution

  • 07333066021201 ()
  • 07333066021287 ()
DECC066630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516749152

Sample Diluent/Wash Powder , 5g
MARDX DIAGNOSTICS, INC.
40-2030
In Commercial Distribution

  • 05391516749152 ()
40-2030

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

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

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
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