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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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Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325000
In Commercial Distribution

  • 05391516743365 ()

  • 96 Tests
2325000

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV VCA P-18 IgG
CLARK LABORATORIES, INC.
2324700
In Commercial Distribution

  • 05391516743334 ()

  • 96 Tests
2324700

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Alkaline Phosphatase Developing Solution, 110mL
MARDX DIAGNOSTICS, INC.
44-5017
In Commercial Distribution

  • 05391516747707 ()
44-5017

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
10x Sample Diluent/Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-2019C
In Commercial Distribution

  • 05391516747653 ()
40-2019C

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346581
In Commercial Distribution

  • 05391516747486 ()

  • 480 Tests
2346581

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007371 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007180 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
IMMUNETICS, INC.
DK-E352-096
In Commercial Distribution

  • 00863782000305 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.
IMMUNO CONCEPTS INC
12075-02 (1)
In Commercial Distribution

  • M749120750211 ()
12075-02 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 9ml.
IMMUNO CONCEPTS INC
12009-02 (1)
In Commercial Distribution

  • M749120090211 ()
12009-02 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
ANCA IgG Fluorescent Antibody Reagent - 1 x 9 mls.
IMMUNO CONCEPTS INC
10009-11 (1)
In Commercial Distribution

  • M749100091111 ()
10009-11 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM3Z9661
In Commercial Distribution

  • 00845533000277 ()
SM3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z9661B
In Commercial Distribution

  • 00845533000260 ()
Q3Z9661B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z9661B
In Commercial Distribution

  • 00845533000253 ()
3Z9661B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z9661
In Commercial Distribution

  • 00845533000246 ()
3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
SM3Z9651
In Commercial Distribution

  • 00845533000239 ()
SM3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651B
In Commercial Distribution

  • 00845533000222 ()
3Z9651B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651
In Commercial Distribution

  • 00845533000215 ()
3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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
In Commercial Distribution

  • 00613745031101 ()

  • 96 tests
3110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
310870
In Commercial Distribution

  • 08056771600262 ()
  • 18056771600269 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
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