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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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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

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 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

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

C-3 (b1c/b1a) RID plate kit - B1761055

Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody

C-3 (b1c/b1a) RID Plate package - B1761054

Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody

IgM RID plate kit - B1761035

Radial immunodiffusion plate package for human IgM with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761035 ()
103511

  • Total immunoglobulin M (IgM total) IVD, antibody

IgM RID plate package - B176103411

Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody
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