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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
63881268659000K914028RUBELLA IGM ELISA TEST SYSTEMLFX1992-04-22
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
MOB112026-08-21
DHN102022-04-29
LSR102012-07-26
MID82011-12-12
LHL81997-06-18
LSE71999-12-22
GQL71991-11-07
LFY62007-07-05
LFX62007-03-21
DDC62000-02-18
LJM61994-06-10
DBM61983-06-15
JRY52005-04-29
JZO52004-03-22
MST51999-03-26
LLL42025-10-22
MXJ42011-04-26
LIP42011-02-10
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
MCD21993-01-11
DEW21992-12-15
LKQ21990-04-26