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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.
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
Bion Enterprises, Ltd.
CHG-4120
In Commercial Distribution

  • B110CHG41200 ()
CHG-4120

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

  • B379STNG11 ()


  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Strongyloides IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3012
In Commercial Distribution

  • B350GSD0130120 ()
GSD01-3012

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Trichinella spiralis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3002
In Commercial Distribution

  • B350GSD0130020 ()
GSD01-3002

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxocara canis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3001
In Commercial Distribution

  • B350GSD0130010 ()
GSD01-3001

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxocara canis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3000
Not in Commercial Distribution

  • B350GSD0130000 ()
GSD01-3000

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
720-300
In Commercial Distribution

  • B3507203000 ()
720-300

  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6125-300
In Commercial Distribution

  • 00816870024097 ()

  • Width: 7.75 Inch
6125-300B

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6125-300
In Commercial Distribution

  • 00816870024080 ()

  • Width: 7.75 Inch
6125-300A

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control
"720-370 Rubella IgM Test Kit"
DIAMEDIX CORPORATION
720-370
In Commercial Distribution

  • 00817273020204 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
"720-360 Rubella IgG Test Kit"
DIAMEDIX CORPORATION
720-360
In Commercial Distribution

  • 00817273020198 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
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