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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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Tinto Toxoplasma gondii ,RPab - B502BSB60450

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB60450 ()
BSB 6045

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

Tinto Toxoplasma gondii, RPab - B502BSB60440

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB60440 ()
BSB 6044

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

Tinto Toxoplasma gondii RPab - B502BSB60430

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB60430 ()
BSB 6043

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

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

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

PreciControl Anti-SARS-CoV-2 - 07613336180167

No Description
Roche Diagnostics GmbH
09216928190
In Commercial Distribution

  • 07613336180167 ()
09216928190

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

CERAMAX - 10603295012719

CERAMAX Ceramic Insert NEUTRAL 60mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-660
In Commercial Distribution

  • 10603295012719 ()
121889660

  • Ceramic acetabular liner
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