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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The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease.
Genbio
800-3110
Not in Commercial Distribution

  • 00613745031101 ()

  • 96 tests
3110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
10x Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-1013
In Commercial Distribution

  • 05391516747721 ()
40-1013

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 00404847461336 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
Not in Commercial Distribution

  • 00404847434507 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.
GERMAINE LABORATORIES, INC
77025
In Commercial Distribution

  • 00695684770259 ()
  • 00695684770251 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma)
DRG International Inc
EIA-3450
In Commercial Distribution

  • 00840239034502 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG International Inc
EIA-6133
Not in Commercial Distribution

  • 00840239061331 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
I-OTS01X
In Commercial Distribution

  • 00813545026066 ()
I-OTS01X

  • Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution

  • 00813545025649 ()
I-ECH01X

  • Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 04048474061338 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
In Commercial Distribution

  • 04048474034509 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
LK009.10.OPT.A
In Commercial Distribution

  • 05051700021043 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK008.10.OPT.A
In Commercial Distribution

  • 05051700021036 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK007.10.OPT.A
In Commercial Distribution

  • 05051700020930 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK006.10.OPT.A
In Commercial Distribution

  • 05051700020923 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK004.10.OPT.A
In Commercial Distribution

  • 05051700020916 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK010.L.OPT.A
In Commercial Distribution

  • 05051700020190 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK004.L.OPT.A
In Commercial Distribution

  • 05051700019835 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Reaction medium for immunochemical determination with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446455
In Commercial Distribution

  • 00842768014246 ()
OUMS65

  • Multiple clinical chemistry protein IVD, reagent
Solution for preparing dilutions for immunochemical determinations with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446457
In Commercial Distribution

  • 00842768011436 ()
OUMT65

  • Buffered sample diluent IVD
Quantitative determination of plasminogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446314
In Commercial Distribution

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent
Quantitative determination of fibrinogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446313
In Commercial Distribution

  • 00842768009945 ()
OSCA09

  • Fibrinogen assay (factor I) IVD, kit, clotting
Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent
Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446307
In Commercial Distribution

  • 00842768009884 ()
OSAW15

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446306
In Commercial Distribution

  • 00842768009877 ()
OSAW09

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446305
In Commercial Distribution

  • 00842768009860 ()
OSAV15

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446304
In Commercial Distribution

  • 00842768009853 ()
OSAV09

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446299
In Commercial Distribution

  • 00842768009808 ()
OSAS19

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446297
In Commercial Distribution

  • 00842768009785 ()
OSAS11

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446295
In Commercial Distribution

  • 00842768009761 ()
OSAR19

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446293
In Commercial Distribution

  • 00842768009747 ()
OSAR11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
This assay is an enzyme immunoassay intended for the quantitative determination of lysozyme in stool.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6100
Not in Commercial Distribution

  • 00404847461008 ()
EIA-6100

  • Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)
Supplementary reagent for multiple protein assays on Siemens systems
Siemens Healthcare Diagnostics Products GmbH
10446458
In Commercial Distribution

  • 00842768011443 ()
OUMU15

  • Buffered isotonic saline reagent IVD
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD
This assay is an enzyme immunoassay intended for the quantitative determination of lysozyme in stool.
DRG International Inc
EIA-6100
Not in Commercial Distribution

  • 00840239061003 ()
EIA-6100

  • Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)
VITROS Chemistry Products IgG Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801733
In Commercial Distribution

  • 10758750006823 ()
  • 20758750006820 ()
6801733

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Fluorescein conjugated polyclonal goat antiserum to Human IgG,IgA, and IgM (polyvalent)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761162 ()
116202

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for human human IgG with three standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761015 ()
101511

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761014 ()
101411

  • Total immunoglobulin G (IgG total) IVD, control
This assay is an enzyme immunoassay intended for the quantitative determination of lysozyme in stool.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6100
Not in Commercial Distribution

  • 04048474061000 ()
EIA-6100

  • Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)
The Dengue Virus NS1 Ag ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6090
In Commercial Distribution

  • 04048474060904 ()
EIA-6090

  • Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
NK004.10S.A
In Commercial Distribution

  • 05051700018296 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
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