Device Description : AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent ImmunoassayFluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay AccuDiag ™ Borrelia burgdorferi IgG/IgM 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.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immuno AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (E AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Mumps IgMA collection of reagents and other associated materials inte AccuDiag ™ Mumps IgMA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Device Class : 1
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ RPR Latex Test KitA collection of reagents and other associated mater AccuDiag ™ RPR Latex Test KitA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No
Device Description : AccuDiag ™ Toxocara IgG ELISAThe Toxocara ELISA test is a qualitative enzyme imm AccuDiag ™ Toxocara IgG ELISAThe Toxocara ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Toxocara, in samples of human serum or plasma.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : Yes
Prescription Use : No
Device Description : AccuDiag ™ Strongyloides IgG ELISAThe Strongyloides ELISA test is a qualitative AccuDiag ™ Strongyloides IgG ELISAThe Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Strongyloides, in samples of human serum or plasma.
Device Class : 1
Duns Number: 878252071
Premarket Exempt : Yes
Prescription Use : No
Device Description : AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EI AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Device Class : 2
Duns Number: 878252071
Premarket Exempt : No
Prescription Use : No