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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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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

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

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 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

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
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