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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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Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 120 Tests
MARDX DIAGNOSTICS, INC.
30-7120
In Commercial Distribution

  • 05391516746151 ()
30-7120

  • Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325800
In Commercial Distribution

  • 05391516743570 ()

  • 96 Tests
2325800

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
QMedix™ EBV VCA IgG ImmunoFlourescent Assay
Diagnostic Automation, Inc.
DACD401010-G
In Commercial Distribution

  • 00850054026613 ()

  • 10, 10-well slides
401010-G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
QMedix™ Lyme IgG/IgM ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1423-55
In Commercial Distribution

  • 00850054026378 ()

  • 96 Tests
1423-55

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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)
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.
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.
3Z9651B
In Commercial Distribution

  • 00845533000222 ()
3Z9651B

  • 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.
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.
3Z9661B
In Commercial Distribution

  • 00845533000253 ()
3Z9661B

  • 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.
3Z9651
In Commercial Distribution

  • 00845533000215 ()
3Z9651

  • 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
AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay method.
Diagnostic Automation, Inc.
DACD1427-2
In Commercial Distribution

  • 00850049545259 ()

  • 96 Tests
1427-2

  • 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.
PF-SM3Z9661
In Commercial Distribution

  • 00845533001854 ()
PF-SM3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is designed for the qualitative and semi-quantitative detection of EBV-VCA IgG antibodies in human serum and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9151G
In Commercial Distribution

  • 00845533001571 ()
FA9151G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
FITC anti-IgG Goat Polyclonal Antibody, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8535-M250
In Commercial Distribution

  • 00615233010575 ()
8535-M250

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8535-C010
In Commercial Distribution

  • 00615233002303 ()
8535-C010

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon Mouse IgG1 (X40) BV786 ASR
Becton, Dickinson And Company
664537
In Commercial Distribution

  • 00382906645371 ()
664537

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon Mouse IgG1 (X40) BV711 ASR
Becton, Dickinson And Company
664526
In Commercial Distribution

  • 00382906645265 ()
664526

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon Mouse IgG1 (X40) V500-C ASR
Becton, Dickinson And Company
647452
In Commercial Distribution

  • 00382906474520 ()
647452

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon™ Mouse IgG1 (X40) BV421
Becton, Dickinson And Company
659453
In Commercial Distribution

  • 00382906594532 ()
659453

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD Horizon™ Mouse IgG1 (X40) V450
Becton, Dickinson And Company
642277
In Commercial Distribution

  • 00382906422774 ()
642277

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD® Mouse IgG1 (X40) APC-Cy7
Becton, Dickinson And Company
348802
In Commercial Distribution

  • 00382903488025 ()
348802

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG2a Isotype Control PerCP X39 ASR
Becton, Dickinson And Company
340765
In Commercial Distribution

  • 00382903407651 ()
340765

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG2a Isotype Control FITC X39 ASR
Becton, Dickinson And Company
340764
In Commercial Distribution

  • 00382903407644 ()
340764

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG2a Isotype Control PE X39 ASR
Becton, Dickinson And Company
340756
In Commercial Distribution

  • 00382903407569 ()
340756

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG1 Isotype Control APC X40 ASR
Becton, Dickinson And Company
340754
In Commercial Distribution

  • 00382903407545 ()
340754

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Ms IgG1 Isotype Control PE-Cy7 X40 ASR
Becton, Dickinson And Company
348798
In Commercial Distribution

  • 00382903487981 ()
348798

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
BD® Mouse IgG1 (X40) PerCP-Cy5.5
Becton, Dickinson And Company
347212
In Commercial Distribution

  • 00382903472123 ()
347212

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2100X
In Commercial Distribution

  • 00845714003479 ()

  • 5 ml
2100X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2100X-8
In Commercial Distribution

  • 00845714003011 ()

  • 8 ml
2100X-8

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2099X
In Commercial Distribution

  • 00845714002991 ()

  • 5 ml
2099X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2100
In Commercial Distribution

  • 00845714002182 ()

  • 5 ml
2100

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2099
In Commercial Distribution

  • 00845714002175 ()

  • 5 ml
2099

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
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)
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