ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC.
PMA#
ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.
FLUORO-CEP (R) PROGESTERONE
ZEUS SCIENTIFIC, INC.
FLUORO-CEP (R) PROGESTERONE
ZEUS SCIENTIFIC, INC.
FLUORO-CEP (R) PROGESTERONE
ZEUS SCIENTIFIC, INC.
PMN#
Zeus IFA ANA HEp-2 Test System, Zeus DIFine
Zeus Scientific, Inc.
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi IgG/IgM Test System
ZEUS Scientific, Inc.
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
ZEUS SCIENTIFIC, INC.
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
ZEUS SCIENTIFIC, INC.
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
ZEUS SCIENTIFIC, INC.
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
ZEUS SCIENTIFIC, INC.
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
ZEUS SCIENTIFIC, INC.
GLIADIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
GLIADIN IGA ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
GUDID#
Herpes Simplex Virus-1 (HSV-1) IgM - FA9051M
2026-06-09
Herpes Simplex Virus-2 (HSV-2) IgG - FA9052G
2026-06-09
Alegria Flash SSA-60 - The Alegria Flash SSA-60 kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to SSA-60 in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SS) and Systemic Lupus Erythematosus (SLE) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-06-08
Alegria Flash SSA-60 Control Kit - CL28001CK
2026-06-08
Alegria Flash SSA-52 - The Alegria Flash SSA-52 kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to SSA-52 in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SJS) and Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SS) and Idiopathic Inflammatory Myopathies (IIM) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-06-08
Alegria Flash SSA-52 Control Kit - CL28011CK
2026-06-08
Alegria Flash SSB - The Alegria Flash SSB kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to SSB (La) in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SS) and Systemic Lupus Erythematosus (SLE) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-06-08
Alegria Flash SSB Control Kit - CL28021CK
2026-06-08
Cytomegalovirus (CMV) IgG - The Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
2026-06-08
Cytomegalovirus (CMV) IgMm - The Cytomegalovirus (CMV) IgM Test System is designed for qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. The Test System is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
2026-06-08
Herpes Simplex Virus-1 (HSV-1) IgG - The Herpes Simplex Virus-1 (HSV-1) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use.
2026-06-08
Herpes Simplex Virus-2 (HSV-2) IgM - The Herpes Simplex Virus-2 (HSV-2) IgM Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use.
2026-06-08
Legionella pneumophila (Group 1-6) - The Legionella pneumophila (Group 1 - 6) is an indirect fluorescent antibody (IFA) assay designed for the detection of L. pneumophila antibodies in human serum, and is for In Vitro diagnostic use.
2026-05-26
Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG - The Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG is designed for the qualitative and semi-quantitative detection of EBV-VCA IgG antibodies in human serum and is for In Vitro diagnostic use.
2026-05-26
Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM - The Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
2026-05-26
Striated Muscle (Rat) - Clinical and experimental evidence strongly suggests that circulating antibodies directed against acetylcholine receptor (AChR) and muscle cell antigens are important in the pathogenesis of myasthenia gravis. Several antibody mediated mechanisms have been implanted in the alteration of neuromuscular transmission, including (1) complement mediated destruction of motor and plates with consequent AChR loss, (2) blockage of the AChR active site preventing AChR access, or (3) alteration of AChR turnover. The positive response to thymectomy in patients with a short history of myasthenia gravis (MG) may be due to alteration of thymic cell populations that normally regulate antibody production
2026-05-15
Alegria Flash PR3 - The Alegria Flash PR3 kit uses chemiluminescent immunoassay (CLIA) technology for the quantitative measurement of IgG antibodies to PR3 in human serum. It is intended for use as an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-05-15
Alegria Flash PR3 Control Kit - The Alegria Flash PR3 Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash PR3 kit. The performance characteristics of the Alegria Flash PR3 Control Kit have not been established for any other assays or instrument platforms.
2026-05-15
Alegria Flash MPO - The Alegria Flash MPO kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to MPO in human serum. It is intended for use as an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-05-15
Alegria Flash MPO Control Kit - The Alegria Flash MPO Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash MPO assay kit. The performance characteristics of the Alegria Flash GBM Control Kit have not been established for any other assays or instrument platforms.
2026-05-15
Alegria Flash GBM - The Alegria Flash GBM kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to GBM in human serum. It is intended for use as an aid in the diagnosis of Goodpasture’s Syndrome in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-05-15
Alegria Flash GBM Control Kit - The Alegria Flash GBM Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash GBM assay kit. The performance characteristics of the Alegria Flash GBM Control Kit have not been established for any other assays or instrument platforms.
2026-05-15
Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT) - The Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT) 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. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
2026-04-15
Anti-SARS-CoV-2 IgG - Anti-SARS-CoV-2 IgG is an ELISA-based test system intended for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. The Anti-SARS-CoV-2 IgG is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Anti-SARS-CoV-2 IgG should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate (automated method) or high (manual and automated method) complexity tests.
2026-04-01
Anti-SARS-CoV-2 Total - Anti-SARS-CoV-2 Total is an ELISA-based test system intended for the qualitative detection of total antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. The Anti-SARS-CoV-2 Total is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Anti-SARS-CoV-2 Total should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate (automated method) or high (manual and automated method) complexity tests.
2026-04-01
Anti-dsDNA - The Anti-dsDNA is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) 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. This device is for In Vitro diagnostic use.
2026-04-01
Anti-dsDNA - The Anti-dsDNA is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) 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. This device is for In Vitro diagnostic use.
2026-04-01
Anti-EBV EA IgG - The Anti-EBV EA IgG provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
2026-04-01
Anti-EBV EA IgG - The Anti-EBV EA IgG provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
2026-04-01
ENA Screen - The ENA Screen is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use.
2026-04-01
ENA Screen - The ENA Screen is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use.
2026-04-01
Anti-Gliadin IgA - The Anti-Gliadin IgA is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
2026-04-01
Anti-Gliadin IgA - The Anti-Gliadin IgA is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
2026-04-01
Anti-Gliadin IgG - The Anti-Gliadin IgG is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
2026-04-01
Anti-Gliadin IgG - The Anti-Gliadin IgG is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
2026-04-01
Anti-HSV gG-1 IgG - The Anti-HSV gG-1 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
2026-04-01
Anti-HSV gG-1 IgG - The Anti-HSV gG-1 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
2026-04-01
Anti-HSV gG-2 IgG - The Anti-HSV gG-2 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
2026-04-01
Anti-HSV gG-2 IgG - The Anti-HSV gG-2 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
2026-04-01
Anti-HSV-1 & 2 IgM - The Anti-HSV-1 & 2 IgM 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.
2026-04-01