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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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ELISA HSV gG-1 IgG Test System - 00845533000666

The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
9Z9761G
In Commercial Distribution

  • 00845533000666 ()
9Z9761G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Human IgG - Particle - ASR pack - 05051700020312

No Description
THE BINDING SITE GROUP LIMITED
MA004
In Commercial Distribution

  • 05051700020312 ()


  • Total immunoglobulin G (IgG total) IVD, reagent

Bio-Rad Laboratories, Inc. - 00847865010702

Toxoplasma IgG EIA
Bio-RAD Laboratories, Inc.
25175
In Commercial Distribution

  • 00847865010702 ()

  • 96 Tests
25175

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

IMMULITE® 2000 Systems FVB Vitamin B12/Folic Acid Sample Diluent - 00630414954455

Folic/B12 Common Sample - IMMULITE - CONS - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387054
In Commercial Distribution

  • 00630414954455 ()
L2FVZ

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

IMMULITE® 2000 Systems TG Thyroglobulin Sample Diluent - 00630414954318

TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387073
In Commercial Distribution

  • 00630414954318 ()
L2TYZ

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

ELISA T. gondii IgG Smart Kit Test System - 00845533001212

The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM8Z8651G
In Commercial Distribution

  • 00845533001212 ()
SM8Z8651G

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

ELISA T. gondii IgG Q Test System - 00845533001205

The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
Q8Z8651GB
In Commercial Distribution

  • 00845533001205 ()
Q8Z8651GB

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

ELISA T. gondii IgG Test System - 00845533001199

The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
8Z8651G
In Commercial Distribution

  • 00845533001199 ()
8Z8651G

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

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)

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

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)

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)

ASI Toxoplasma IgG EIA Test - 00816057020539

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)

K-ASSAY® IgG Reagent - 00816426020108

For the quantitative determination of human IgG in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-014
In Commercial Distribution

  • 00816426020108 ()
KAI-014

  • Total immunoglobulin G (IgG total) IVD, reagent

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)

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

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)

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

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)
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