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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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No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
BBN-6110
In Commercial Distribution

  • B110BBN61100 ()
BBN-6110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8001-96
In Commercial Distribution

  • 00811727015150 ()
T81001-96

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
PN-8510
Not in Commercial Distribution

  • B110PN85100 ()
PN-8510

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
PG-8520
Not in Commercial Distribution

  • B110PG85200 ()
PG-8520

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
No Description
INBIOS INTERNATIONAL, INC
STNG-1
In Commercial Distribution

  • B379STNG11 ()


  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
TN-96
In Commercial Distribution

  • 00813545026493 ()
TN-96

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
TC-96
In Commercial Distribution

  • 00813545026486 ()
TC-96

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Detection of Toxoplasma Antibody
ARLINGTON SCIENTIFIC, INC.
NC-810096-AG
In Commercial Distribution

  • 00816057020539 ()

  • 96 Test
NC-810096-AG

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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