FDA.reportPublic FDA data

ZEUS SCIENTIFIC LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22424362242436ZEUS SCIENTIFIC LLC1N2026-01-01200 EVANS WAY BRANCHBURG NJ US 08876

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
63881870829135P150045ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEMMYL2017-09-19
63881953707407P150042ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEMMYM2017-09-19
63881222244030K993034MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESDMVM1999-11-01
63881280029688K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMLSE1999-12-22
63881828494195K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODILYR1999-08-12
63882026340696K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.DDC1999-06-25
63881917955829K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMDDC1999-06-17
63881540792046K990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODYDHN1999-04-21
63881849748569K990207GLIADIN IGA ELISA TEST SYSTEMMST1999-03-26
63881844368616K990204GLIADIN IGG ELISA TEST SYSTEMMST1999-03-26
63882028767771K983656HSV-1 AND/OR -2 IGM ELISA TEST SYSTEMLGC1999-03-18
63881705607191K983457OSTEOMARK NTX SERUM EIAJMM1999-02-02
63881045676635K981929BINDAZYME ANTIGLIADIN IGG/IGA COMBI KITMST1998-09-03
63881980449512K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISALSE1998-08-21
63881115637585K981021ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEMMID1998-06-02
63881925608300K981020ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEMMID1998-05-18
63881476073617K981014ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEMMID1998-06-02
63881815856431K980821HELICOBACTER PYLORI IGG ELISA TEST SYSTEMLYR1998-07-30
63881070260193K980638ADI SYPHILIS RPR LIQUID CONTROLSGMP1998-07-06
63881428610258K980518OSTEOMARKJMM1998-03-06
63881976591472K972873IMMUSTRIP HAMA IGGDAK1998-03-17
63881489492229K971503MYCOPLASMA IGM ELISA TEST SYSTEMLJZ1997-08-20
63881766543169K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESDHN1997-02-20
63881872469857K970150MYCOPLASMA IGG ELISA TEST SYSTEMLJZ1997-06-16
63881830530955K970149LEGIONELLA ELISA TEST SYSTEMLHL1997-06-18
63881109976259K964449ANCA SCREEN ELISA TEST SYSTEMMOB1997-04-10
63881261311396K964448PROTEINASE-3 IGG ELISA TEST SYSTEMMOB1997-04-10
63881950340395K964446MYELOPEROXIDASE ELISA TEST SYSTEMMOB1997-04-10
63881045739195K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESMOB1996-09-30
63881710981663K961277RF IGM ELISA TEST SYSTEMDHR1996-05-08
63881357873765K961204MUMPS IGG TESTLJY1996-07-18
63881632967663K961012VZV IGG ELISA TEST SYSTEMLFY1996-07-24
63881453445086K953495EIA KIT FOR THE DETECTION OF GBM ANTIBODIESDBL1996-04-10
63882055335382K944449EBV-VCA IGM ELISA TEST STSTEMLSE1995-09-25
63881637031595K941409ENA PROFILE-6 ELISA TEST SYSTEMLJM1994-06-10
63881649727692K941014ENA SCREEN ELISA TEST SYSTEMLJM1994-06-10
63881857378834K940362ANA SCREEN ELISA TEST SYSTEMLLL1994-07-28
63881461157126K933267AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEMLJM1993-12-15
63881897946925K932742EBNA IGG ELISA TEST SYSTEMLLM1995-05-05
63881340326711K924882TOXOPLASMA IGM IFA TEST SYSTEMGLZ1993-03-23
63881458428637K924197ZORBA(TM) IGG REMOVAL REAGENTDEW1992-12-15
63881212627561K924091EBV-VCA IGG ELISA TEST SYSTEMMCD1993-01-11
63882048332663K914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYLKI1992-02-19
63881268659000K914028
63881748421798K913787TOXOPLASMA IGM ELISA TEST SYSTEMLGD1991-12-18
63882049497983K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1GQL1991-11-07
63881159881004K902237MEDICA IIF ANTI-SKIN ANTIBODY TEST KITDBL1990-07-09
63881054293989K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.JRY1990-04-16
63882067789344K900743CMV-IGM IFA TEST SYSTEMLKQ1990-04-26
63881279314587K900196LYME IGM ELISA TEST SYSTEMLSR1990-05-02
63881996362408K897025ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEMDHN1990-01-02
63881665066222K896355CMV IGM ELISA TEST SYSTEMLFZ1990-02-27
63881756696795K895292LYME IGG ELISA TEST SYSTEMLSR1989-12-13
63881693349629K891783RUBELLA ELISA TEST SYSTEMLFX1989-08-03
63881453295327K891782HSV-2 ELISA TEST SYSTEMGQL1989-06-20
63881702240492K891781TOXO ELISA TEST SYSTEMLGD1989-07-14
63881183052898K891162HSV-1 ELISA TEST SYSTEMGQL1989-06-20
63881974258653K891081CMV ELISA TEST SYSTEMLFZ1989-06-02
63881083291741K885317LYME ELISA TEST SYSTEMLSR1989-03-02
63882005083276K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)GQH1988-12-05
63881235174279K882447EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TESLSE1988-12-15
63881499442690K882440EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TESTLLM1988-12-15
63881032172102K880477RPR TEST FOR SYPHILIS IN SERUM OR PLASMAGMQ1988-03-30
63881514365115K880165TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAGMQ1988-03-30
63881780716125K871246IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERILSR1987-08-25
63881541635074K843343MEDICA IIF-ANTI-THYROID ANTIBODY TESTJZO1984-10-22
63881379149687K841434VARICELLA-ZOSTER(IGG) IFA TESTGQW1985-04-19
63881907701944K833014EBV-VCA-IGM IFA TEST SYSTEMLJN1983-12-27
63881662414221K832896LEGIONELLA INDIRECT FLUORESCENT ANTIBODLHL1983-10-14
63882065228070K831358AUTOANTIBODY SCREEN TEST SYSTEMDBM1983-06-15
63881899680229K831100MEDICA IIF-MULTIPLE ANTIBODY TEST KITDBM1983-05-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOB102025-05-07
DHN102022-04-29
LSR102012-07-26
MID82011-12-12
LHL81997-06-18
LSE71999-12-22
GQL71991-11-07
LFY62007-07-05
DDC62000-02-18
LJM61994-06-10
DBM61983-06-15
JRY52005-04-29
JZO52004-03-22
MST51999-03-26
MXJ42011-04-26
LIP42011-02-10
LFX42007-03-21
LJN42005-04-12
DHR42004-02-27
LYR41999-08-12
LJZ41997-08-20
DBL41996-04-10
LLM41995-05-05
GLZ41993-03-23
LGD41991-12-18
LFZ41990-02-27
LKJ32004-10-08
GQH31988-12-05
DBE31979-04-23
MYF22011-05-20
OPM22010-07-16
MVJ22007-12-06
LGC21999-03-18
JMM21999-02-02
DAK21998-03-17
LJY21996-07-18
LLL21994-07-28
MCD21993-01-11
DEW21992-12-15
LKQ21990-04-26

PMA#

PMN#

137 records. Showing 1-40. Next

GUDID#

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

ZEUS SCIENTIFIC, INC.

2026-05-15

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.

ZEUS SCIENTIFIC, INC.

2026-04-01

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

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.

ZEUS SCIENTIFIC, INC.

2026-04-01

80 records. Showing 1-40. Next