ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.
ZEUS SCIENTIFIC LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2242436 | 2242436 | ZEUS SCIENTIFIC LLC | 1 | N | 2026-01-01 | 200 EVANS WAY BRANCHBURG NJ US 08876 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 6388 | 1870829135 | P150045 | ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM | MYL | 2017-09-19 |
| 6388 | 1953707407 | P150042 | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM | MYM | 2017-09-19 |
| 6388 | 1222244030 | K993034 | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD | MVM | 1999-11-01 |
| 6388 | 1280029688 | K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | LSE | 1999-12-22 |
| 6388 | 1828494195 | K991820 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI | LYR | 1999-08-12 |
| 6388 | 2026340696 | K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | DDC | 1999-06-25 |
| 6388 | 1917955829 | K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | DDC | 1999-06-17 |
| 6388 | 1540792046 | K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | DHN | 1999-04-21 |
| 6388 | 1849748569 | K990207 | GLIADIN IGA ELISA TEST SYSTEM | MST | 1999-03-26 |
| 6388 | 1844368616 | K990204 | GLIADIN IGG ELISA TEST SYSTEM | MST | 1999-03-26 |
| 6388 | 2028767771 | K983656 | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | LGC | 1999-03-18 |
| 6388 | 1705607191 | K983457 | OSTEOMARK NTX SERUM EIA | JMM | 1999-02-02 |
| 6388 | 1045676635 | K981929 | BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT | MST | 1998-09-03 |
| 6388 | 1980449512 | K981120 | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | LSE | 1998-08-21 |
| 6388 | 1115637585 | K981021 | ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM | MID | 1998-06-02 |
| 6388 | 1925608300 | K981020 | ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM | MID | 1998-05-18 |
| 6388 | 1476073617 | K981014 | ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM | MID | 1998-06-02 |
| 6388 | 1815856431 | K980821 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM | LYR | 1998-07-30 |
| 6388 | 1070260193 | K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | GMP | 1998-07-06 |
| 6388 | 1428610258 | K980518 | OSTEOMARK | JMM | 1998-03-06 |
| 6388 | 1976591472 | K972873 | IMMUSTRIP HAMA IGG | DAK | 1998-03-17 |
| 6388 | 1489492229 | K971503 | MYCOPLASMA IGM ELISA TEST SYSTEM | LJZ | 1997-08-20 |
| 6388 | 1766543169 | K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | DHN | 1997-02-20 |
| 6388 | 1872469857 | K970150 | MYCOPLASMA IGG ELISA TEST SYSTEM | LJZ | 1997-06-16 |
| 6388 | 1830530955 | K970149 | LEGIONELLA ELISA TEST SYSTEM | LHL | 1997-06-18 |
| 6388 | 1109976259 | K964449 | ANCA SCREEN ELISA TEST SYSTEM | MOB | 1997-04-10 |
| 6388 | 1261311396 | K964448 | PROTEINASE-3 IGG ELISA TEST SYSTEM | MOB | 1997-04-10 |
| 6388 | 1950340395 | K964446 | MYELOPEROXIDASE ELISA TEST SYSTEM | MOB | 1997-04-10 |
| 6388 | 1045739195 | K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES | MOB | 1996-09-30 |
| 6388 | 1710981663 | K961277 | RF IGM ELISA TEST SYSTEM | DHR | 1996-05-08 |
| 6388 | 1357873765 | K961204 | MUMPS IGG TEST | LJY | 1996-07-18 |
| 6388 | 1632967663 | K961012 | VZV IGG ELISA TEST SYSTEM | LFY | 1996-07-24 |
| 6388 | 1453445086 | K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | DBL | 1996-04-10 |
| 6388 | 2055335382 | K944449 | EBV-VCA IGM ELISA TEST STSTEM | LSE | 1995-09-25 |
| 6388 | 1637031595 | K941409 | ENA PROFILE-6 ELISA TEST SYSTEM | LJM | 1994-06-10 |
| 6388 | 1649727692 | K941014 | ENA SCREEN ELISA TEST SYSTEM | LJM | 1994-06-10 |
| 6388 | 1857378834 | K940362 | ANA SCREEN ELISA TEST SYSTEM | LLL | 1994-07-28 |
| 6388 | 1461157126 | K933267 | AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM | LJM | 1993-12-15 |
| 6388 | 1897946925 | K932742 | EBNA IGG ELISA TEST SYSTEM | LLM | 1995-05-05 |
| 6388 | 1340326711 | K924882 | TOXOPLASMA IGM IFA TEST SYSTEM | GLZ | 1993-03-23 |
| 6388 | 1458428637 | K924197 | ZORBA(TM) IGG REMOVAL REAGENT | DEW | 1992-12-15 |
| 6388 | 1212627561 | K924091 | EBV-VCA IGG ELISA TEST SYSTEM | MCD | 1993-01-11 |
| 6388 | 2048332663 | K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | LKI | 1992-02-19 |
| 6388 | 1268659000 | K914028 | RUBELLA IGM ELISA TEST SYSTEM | LFX | 1992-04-22 |
| 6388 | 1748421798 | K913787 | TOXOPLASMA IGM ELISA TEST SYSTEM | LGD | 1991-12-18 |
| 6388 | 2049497983 | K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | GQL | 1991-11-07 |
| 6388 | 1159881004 | K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | DBL | 1990-07-09 |
| 6388 | 1054293989 | K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | JRY | 1990-04-16 |
| 6388 | 2067789344 | K900743 | CMV-IGM IFA TEST SYSTEM | LKQ | 1990-04-26 |
| 6388 | 1279314587 | K900196 | LYME IGM ELISA TEST SYSTEM | LSR | 1990-05-02 |
| 6388 | 1996362408 | K897025 | ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM | DHN | 1990-01-02 |
| 6388 | 1665066222 | K896355 | CMV IGM ELISA TEST SYSTEM | LFZ | 1990-02-27 |
| 6388 | 1756696795 | K895292 | LYME IGG ELISA TEST SYSTEM | LSR | 1989-12-13 |
| 6388 | 1693349629 | K891783 | RUBELLA ELISA TEST SYSTEM | LFX | 1989-08-03 |
| 6388 | 1453295327 | K891782 | HSV-2 ELISA TEST SYSTEM | GQL | 1989-06-20 |
| 6388 | 1702240492 | K891781 | TOXO ELISA TEST SYSTEM | LGD | 1989-07-14 |
| 6388 | 1183052898 | K891162 | HSV-1 ELISA TEST SYSTEM | GQL | 1989-06-20 |
| 6388 | 1974258653 | K891081 | CMV ELISA TEST SYSTEM | LFZ | 1989-06-02 |
| 6388 | 1083291741 | K885317 | LYME ELISA TEST SYSTEM | LSR | 1989-03-02 |
| 6388 | 2005083276 | K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | GQH | 1988-12-05 |
| 6388 | 1235174279 | K882447 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES | LSE | 1988-12-15 |
| 6388 | 1499442690 | K882440 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST | LLM | 1988-12-15 |
| 6388 | 1032172102 | K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | GMQ | 1988-03-30 |
| 6388 | 1514365115 | K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | GMQ | 1988-03-30 |
| 6388 | 1780716125 | K871246 | IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI | LSR | 1987-08-25 |
| 6388 | 1541635074 | K843343 | MEDICA IIF-ANTI-THYROID ANTIBODY TEST | JZO | 1984-10-22 |
| 6388 | 1379149687 | K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | GQW | 1985-04-19 |
| 6388 | 1907701944 | K833014 | EBV-VCA-IGM IFA TEST SYSTEM | LJN | 1983-12-27 |
| 6388 | 1662414221 | K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | LHL | 1983-10-14 |
| 6388 | 2065228070 | K831358 | AUTOANTIBODY SCREEN TEST SYSTEM | DBM | 1983-06-15 |
| 6388 | 1899680229 | K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | DBM | 1983-05-04 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MOB | 10 | 2025-05-07 |
| DHN | 10 | 2022-04-29 |
| LSR | 10 | 2012-07-26 |
| MID | 8 | 2011-12-12 |
| LHL | 8 | 1997-06-18 |
| LSE | 7 | 1999-12-22 |
| GQL | 7 | 1991-11-07 |
| LFY | 6 | 2007-07-05 |
| LFX | 6 | 2007-03-21 |
| DDC | 6 | 2000-02-18 |
| LJM | 6 | 1994-06-10 |
| DBM | 6 | 1983-06-15 |
| JRY | 5 | 2005-04-29 |
| JZO | 5 | 2004-03-22 |
| MST | 5 | 1999-03-26 |
| MXJ | 4 | 2011-04-26 |
| LIP | 4 | 2011-02-10 |
| LJN | 4 | 2005-04-12 |
| DHR | 4 | 2004-02-27 |
| LYR | 4 | 1999-08-12 |
| LJZ | 4 | 1997-08-20 |
| DBL | 4 | 1996-04-10 |
| LLM | 4 | 1995-05-05 |
| GLZ | 4 | 1993-03-23 |
| LGD | 4 | 1991-12-18 |
| LFZ | 4 | 1990-02-27 |
| LKJ | 3 | 2004-10-08 |
| GQH | 3 | 1988-12-05 |
| DBE | 3 | 1979-04-23 |
| MYF | 2 | 2011-05-20 |
| OPM | 2 | 2010-07-16 |
| MVJ | 2 | 2007-12-06 |
| LGC | 2 | 1999-03-18 |
| JMM | 2 | 1999-02-02 |
| DAK | 2 | 1998-03-17 |
| LJY | 2 | 1996-07-18 |
| LLL | 2 | 1994-07-28 |
| MCD | 2 | 1993-01-11 |
| DEW | 2 | 1992-12-15 |
| LKQ | 2 | 1990-04-26 |
PMA#
ZEUS ELISA PARVOVIRUS B19 IGG 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#
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
Zeus Scientific
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
Zeus Scientific
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Zeus Scientific
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 Test System
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 VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi 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 TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
ZEUS SCIENTIFIC, INC. (ZEUS)
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 TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
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.
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC.
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
ZEUS SCIENTIFIC, INC.
BORRELIA BURGDORFERI IGM WESTERN BLOT 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.
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-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
ZEUS SCIENTIFIC, INC.
GUDID#
Herpes Simplex Virus-2 (HSV-2) IgG - FA9052G
2026-06-09
Herpes Simplex Virus-1 (HSV-1) IgM - FA9051M
2026-06-09
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
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
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
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
Alegria Flash SSB Control Kit - CL28021CK
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 SSA-52 Control Kit - CL28011CK
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-60 Control Kit - CL28001CK
2026-06-08
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
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
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
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
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
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 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 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 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 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
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
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
Cardiac Muscle Primate - Demonstration of Cardiac Muscle Antibody (CMA) by utilizing the indirect fluorescent antibody method enables serologic assessment or possible detection of cardiac disease. The presence of a (histologically defined) circulating antibody to one or more of the cardiac muscle antigens can aid in patient diagnosis and prognosis of such disease as; rheumatic fever, myocardial infarction and a variety of post-cardiotomy states. The substrate utilized in this kit is sections of monkey heart.
2026-04-01
Alegria Flash CTD Screen - The Alegria Flash CTD Screen is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to SSA-60, SSA-52, SS-B, Jo-1, Scl-70, SmRNP, Sm, dsDNA, Ribosomal P, Nucleosome, and Centromere-B in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD): Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-04-01
Alegria Flash CTD Screen Control Kit - The Alegria Flash CTD Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to SSA-60, SSA-52, SS-B, Jo-1, Scl-70, SmRNP, Sm, dsDNA, Ribosomal P, Nucleosome, and Centromere-B in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD): Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
2026-04-01
Parvovirus B19 IgG/IgM - The Parvovirus B19 Immunofluorescent Assay is intended for the qualitative and semi-quantitative detection of anti-Parvovirus B19 IgG and IgM antibodies in human serum. The test is indicated for use in all women where there is a suspicion of exposure to Parvovirus B19 to determine the presence of a recent or current infection.
2026-04-01
Reticulin IgA (Rat Liver/Kidney/Stomach) - The use of rat liver/kidney/stomach tissue can be utilized to screen for reticulin antibodies by immunofluorescence. There are a variety of staining patterns associated with the mesenchymal structures in the liver, kidney and other organs.1 Many sera appear to contain a mixture of antibodies and stain cells, ground substances and fibers in various combinations. These antibodies may appear individually, and attempts have been made to access their occurrence as they relate to specific diseases.
2026-04-01
Reticulin IgG (Rat Liver/Kidney/Stomach) - The use of rat liver/kidney/stomach tissue can be utilized to screen for reticulin antibodies by immunofluorescence. There are a variety of staining patterns associated with the mesenchymal structures in the liver, kidney and other organs.1 Many sera appear to contain a mixture of antibodies and stain cells, ground substances and fibers in various combinations. These antibodies may appear individually, and attempts have been made to access their occurrence as they relate to specific diseases.
2026-04-01
Anti-TPO - The Anti-TPO is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
2026-04-01
Anti-TPO - The Anti-TPO is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
2026-04-01
Anti-T. gondii IgG - The Anti-T. gondii IgG is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
2026-04-01
Anti-T. gondii IgG - The Anti-T. gondii IgG is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
2026-04-01
Anti-TG - The Anti-TG is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
2026-04-01
Anti-TG - The Anti-TG is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
2026-04-01
Anti-T. pallidum IgG - The Anti-T. pallidum IgG is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
2026-04-01
Anti-T. pallidum IgG - The Anti-T. pallidum IgG is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
2026-04-01
Anti-Measles Virus IgG - The Anti-Measles Virus IgG is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
2026-04-01
Anti-Measles Virus IgG - The Anti-Measles Virus IgG is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
2026-04-01
Anti-Measles Virus IgG - The Anti-Measles Virus IgG is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
2026-04-01