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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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Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System - B110RS90120

No Description
Bion Enterprises, Ltd.
RS-9012
In Commercial Distribution

  • B110RS90120 ()
RS-9012

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, reagent

EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System - B110NA51120

No Description
Bion Enterprises, Ltd.
NA-5112
Not in Commercial Distribution

  • B110NA51120 ()
NA-5112

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent

Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System - B110IB21120

No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

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

Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System - B110IA11120

No Description
Bion Enterprises, Ltd.
IA-1112
In Commercial Distribution

  • B110IA11120 ()
IA-1112

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent

Herpes Simplex IgG Control - B110HSG35200

No Description
Bion Enterprises, Ltd.
HSG-3520
In Commercial Distribution

  • B110HSG35200 ()
HSG-3520

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

HYTEC Penicillium notatum - 00816879022377

No Description
HYCOR BIOMEDICAL LLC
M001
Not in Commercial Distribution

  • 00816879022377 ()
74383

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

HYTEC Cow Dander - 00816879022353

No Description
HYCOR BIOMEDICAL LLC
E004
Not in Commercial Distribution

  • 00816879022353 ()
74220

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

HYTEC Blackberry, Rubus fruitcosus - 00816879025972

No Description
HYCOR BIOMEDICAL LLC
F211
Not in Commercial Distribution

  • 00816879025972 ()
746040

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Toxoplasma gondii RPab - B502BSB60480

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB60480 ()
BSB 6048

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Toxoplasma gondii RPab - B502BSB60470

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB60470 ()
BSB 6047

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
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