Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242436

FEI Number

2242436

Entity Name

ZEUS SCIENTIFIC LLC

City/State/Country

BRANCHBURG, NJ, US

Establishment Address

200 EVANS WAY, BRANCHBURG, NJ 08876, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZEUS SCIENTIFIC LLC (Owner Number: 2242436)

Owner / Operator Contact Address

200 EVANS WAY, --, Branchburg, NJ 08876, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970149

PMA Number

N/A

All Registered Proprietary Names

MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL General purpose reagent ANTISMOOTH MUSCLE ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL Autoantibodies, endomysial(tissue transglutaminase) REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT ANTIGENS, NONTREPONEMAL, ALL ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE ANTISERA, CONTROL FOR NONTREPONEMAL TESTS ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS SYSTEM, TEST, THYROID AUTOANTIBODY ANTISMOOTH MUSCLE ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTISERUM, FLUORESCENT, EPSTEIN-BARR VIRUS Autoantibodies, endomysial(tissue transglutaminase) ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTIGENS, NONTREPONEMAL, ALL ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL AtheNA Multi-Lyte® RF IgM Plus Test System REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT ZEUS IFA ANA HEp-2 Test System ZEUS dIFine® Digital Scanner and Software ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL REAGENT, RICKETTSIA SEROLOGICAL Antisera, fluorescent, herpesvirus hominis 1,2 MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL SYSTEM, TEST, THYROID AUTOANTIBODY AtheNA Multi-Lyte® MMRV IgG Plus Test System ANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL ANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	1992-07-14
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2007-03-19
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2025-06-06
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2013-04-23
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-06-06
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2013-04-23
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2012-05-10
DBE	Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5120	2025-06-06
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2013-04-23
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2025-06-06
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2025-07-07
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2012-05-10
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	1992-07-14
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2025-06-04
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Microbiology	Class 2	866.3175	2012-05-10
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2012-12-21
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2025-06-06
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2025-06-06
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2007-03-19
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2012-05-10
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2013-04-23
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-05-03
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2025-06-06
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2025-06-06
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2012-05-10
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster	Microbiology	Class 2	866.3900	2007-03-19
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2013-04-23
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-04-23
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2013-04-23
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2025-06-06
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2025-06-06
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2013-04-23
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2012-05-10
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-04-23
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2012-02-15
GQC	Antisera, Cf, Equine Encephalitis Virus, Eee, Wee	Microbiology	Class 1	866.3240	2025-06-06
MYM	Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	Unknown	Class 3	N/A	2020-07-28
GMP	Antisera, Control For Nontreponemal Tests	Microbiology	Class 2	866.3820	2025-06-06
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2007-03-19
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2012-02-15
DBE	Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5120	2012-05-10
GMS	Anti-Human Globulin, Fta-Abs Test	Microbiology	Class 2	866.3830	2012-05-10
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Microbiology	Class 2	866.3175	2025-06-06
MCD	Antigen, Ebv, Capsid	Microbiology	Class 1	866.3235	1992-07-14
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2023-03-28
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-06-06
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2013-04-23
DBE	Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5120	2025-07-07
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2025-05-22
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2025-05-22
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2013-04-23
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2013-04-23
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2025-06-06
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2012-05-10
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	1992-07-14
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2025-06-06
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2025-06-06
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2013-04-23
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-03-19
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2025-07-07
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2025-06-06
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2013-04-23
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-03-19
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2013-04-23
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2013-04-23
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2025-06-06
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2013-04-23
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	1996-07-23
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2025-06-06
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2022-06-27
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2022-06-27
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2015-04-09
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2025-07-07
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	1996-08-13
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Microbiology	Class 2	866.3175	2007-03-19
LSQ	Reagent, Rickettsia Serological	Microbiology	Class 1	866.3500	2025-06-06
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2013-04-25
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2025-06-06
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2025-07-07
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	1994-07-01
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2012-02-15
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2013-04-25
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-07-07
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	1992-07-14
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-03-19
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2013-04-23
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2013-04-23
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-04-23
OPM	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2	Microbiology	Class 2	866.3510	2013-04-23
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2013-04-23
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	1997-07-17
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2013-05-01
MYL	Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg	Unknown	Class 3	N/A	2020-07-28
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2015-03-02
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2013-04-25
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	1996-08-13
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2013-04-23
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2012-02-15
DBJ	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5110	2025-07-07
DBJ	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5110	2025-06-06
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2013-04-23
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-05-03
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2013-04-23
GLZ	Antigens, If, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-05-01
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	1994-09-09
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2013-04-23
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-03-19
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2013-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZEUS SCIENTIFIC LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820088	Calbiochem-Behring Corp.	AFT SYSTEM PROFICIENCY TESTING PROGRAM	1982-01-26
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K963251	Ciba Corning Diagnostics Corp.	CIBA CORNING ACS;180 DPD ASSAY	1996-10-15
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	1	IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
Z-0081-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242436. Last updated year: 2026. Please use registration number 2242436 when referencing this establishment in official correspondence.