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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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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

Influenza B IgG ELISA Test Kit - B350GSD0130100

Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza A IgG ELISA Test Kit - B350GSD0130090

Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Influenza Virus B IgG - ENTIINFG03000

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Influenza Virus A IgG - ENTIINFG02900

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IgA / FITC control slides - B502BSB3005CS0

IgA / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3005CS0 ()
BSB 3005-CS

  • Immunoglobulin A antibody (anti-IgA) IVD, control

IgA control slides - B502BSB36850

IgA Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36850 ()
BSB 3685

  • Immunoglobulin A antibody (anti-IgA) IVD, control

Influenza A & B Virus Antigen Control Slide, 4 wells - B110QAB15040

No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • Influenza A/B virus antigen IVD, control

IgA Control Slides - B502BSB56650

IgA, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56650 ()
BSB 5665

  • Total immunoglobulin A (IgA total) IVD, control
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