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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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SATB2 RMab - B502BSB32020

SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB32020 ()
BSB 3202

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

SATB2 RMab - B502BSB32010

SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB32010 ()
BSB 3201

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

Tinto SATB2 RMab - B502BSB31990

SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB31990 ()
BSB 3199

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

Tinto SATB2, RMab - B502BSB31980

Tinto SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB31980 ()
BSB 3198

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

Tinto SATB2 RMab - B502BSB31970

SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB31970 ()
BSB 3197

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

Anisakidae IgG ELISA - 07640158219805

The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection of Anisakidae antibodies in human serum samples.
Bordier affinity products S.A.
9800
In Commercial Distribution

  • 07640158219805 ()
9800

  • Anisakis species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trichinella spiralis IgG ELISA - 07640158219751

The Trichinella spiralis ELISA test is a qualitative enzyme immunoassay for the detection of Trichinella spiralis in human serum samples.
Bordier affinity products S.A.
9750
In Commercial Distribution

  • 07640158219751 ()
9750

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Strongyloides ratti IgG ELISA - 07640158219454

The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of Strongyloides antibodies in human serum samples.
Bordier affinity products S.A.
9450
In Commercial Distribution

  • 07640158219454 ()
9450

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Ascaris IgG ELISA - 07640158219256

The Ascaris ELISA test is a qualitative enzyme immunoassay for the detection of Ascaris in human serum samples.
Bordier affinity products S.A.
9250
In Commercial Distribution

  • 07640158219256 ()
9250

  • Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Toxocara canis IgG ELISA - 07640158219201

The Toxocara canis ELISA test is a qualitative enzyme immunoassay for the detection of Toxocara canis antibodies in human serum samples.
Bordier affinity products S.A.
9200
In Commercial Distribution

  • 07640158219201 ()
9200

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Parainfluenza 1, 2, & 3 Negative Control - B110PN85100

No Description
Bion Enterprises, Ltd.
PN-8510
Not in Commercial Distribution

  • B110PN85100 ()
PN-8510

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control

Parainfluenza 1, 2, & 3 IgG Control - B110PG85200

No Description
Bion Enterprises, Ltd.
PG-8520
Not in Commercial Distribution

  • B110PG85200 ()
PG-8520

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control

Chlamydia IgG Control - B110CHG41200

No Description
Bion Enterprises, Ltd.
CHG-4120
In Commercial Distribution

  • B110CHG41200 ()
CHG-4120

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, control

Coxsackie B1-B6 Negative Control - B110CBN33100

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

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Coxsackie B1-B6 IgG Control - B110CBG33200

No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Borrelia Negative Control - B110BBN61100

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 - 00811727015150

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)

Trichinella Antibody 96 Tests - 00813545026493

No Description
SCIMEDX CORPORATION
TN-96
In Commercial Distribution

  • 00813545026493 ()
TN-96

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Toxocara Antibody 96 Tests - 00813545026486

No Description
SCIMEDX CORPORATION
TC-96
In Commercial Distribution

  • 00813545026486 ()
TC-96

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Strongy DetectTM IgG ELISA - B379STNG11

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 - B350GSD0130120

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 - B350GSD0130020

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 - B350GSD0130010

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)

GSD Toxocara canis IgG ELISA - B350GSD0130000

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 - B3507203000

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)

Toxo IgG AccuBind ELISA Test System - 192 Wells - 00816870024097

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)

Toxo IgG AccuBind ELISA Test System - 96 Wells - 00816870024080

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)

Monobind Qsure H. Pylori Control Set - 00816870020211

No Description
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control

Diamedix - 00817273020204

"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

Diamedix - 00817273020198

"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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