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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
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
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
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)
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)
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)
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)
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)
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)
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 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
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 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
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
No Description
INBIOS INTERNATIONAL, INC
STNG-1
In Commercial Distribution

  • B379STNG11 ()


  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS ® TOXO IgG Avidity assay is a qualitative IA intended for use on VIDAS family instrument for the determination of anti - toxoplasma IgG avidity in human serum.
BIOMERIEUX SA
30222-01
In Commercial Distribution

  • 03573026263010 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
ORTHO-CLINICAL DIAGNOSTICS, INC.
719810
In Commercial Distribution

  • 10758750004072 ()
719810

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
AccuDiag™ Trichinella IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to the parasitic nematode Trichinella species in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8207-35
In Commercial Distribution

  • 00894175000626 ()

  • 96 Tests
8207-35

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Strongyloides IgG ELISA The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Strongyloides, in samples of human serum or plasma.
Diagnostic Automation, Inc.
DACD 8319-35
In Commercial Distribution

  • 00894175000121 ()

  • 96 Tests
8319-35

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Toxocara IgG ELISA The Toxocara ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Toxocara, in samples of human serum or plasma.
Diagnostic Automation, Inc.
DACD 8206-35
In Commercial Distribution

  • 00894175000107 ()

  • 96 Tests
8206-35

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
318331
In Commercial Distribution

  • 08056771602716 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
DIASORIN SPA
310541
In Commercial Distribution

  • 08056771101813 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
HSV-1 IgG Calibrator
Abbott Ireland Diagnostics
04W2002
In Commercial Distribution

  • 00380740213879 ()
04W2002

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Toxo IgG Calibrators
Abbott GmbH
07P4504
In Commercial Distribution

  • 00380740203177 ()
07P4504

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator
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)
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)
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)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2290-9601 G
In Commercial Distribution

  • 04049016131601 ()


  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2311-9601 G
In Commercial Distribution

  • 04049016141112 ()


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