Data / Medical devices / United States / Zeus Scientific LLC

Zeus Scientific LLC: FDA-registered device maker in Branchburg, NJ, United States, 112 510(k) clearances and 2 PMA approvals

Name: Zeus Scientific LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zeus Scientific LLC is registered with the FDA (registration 2242436) in Branchburg, NJ, United States. It lists 61 device types. The FDA files 112 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 21, 2026. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Zeus Scientific LLC

FDA registration number: 2242436
Address: 200 Evans Way, Branchburg, NJ, United States, 08876
Owner or operator: ZEUS SCIENTIFIC LLC (2242436)
Roles: Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: July 14, 1992
Registered through: 2026
Brand names listed: ANA HEp-2, ANTI-DNA INDIRECT IMMUNOFLUORESCENT SOLID PHASE, ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS, ANTIGENS, NONTREPONEMAL, ALL, ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL, ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL, ANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL, ANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE and more

Devices it lists

Device	Product code	Class	Role	Source
Anti-Dna Indirect Immunofluorescent Solid Phase	KTL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Anti-Human Globulin, Fta-Abs Test	GMS	2	Manufacturer	accessdata.fda.gov
Anti-Ss-A 52 Autoantibodies	OBE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Anti-Ss-A Ro60 Autoantibodies	PET	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Manufacturer	accessdata.fda.gov
Antibody Igm, If, Epstein-Barr Virus	LJN	1	Manufacturer	accessdata.fda.gov
Antibody Igm,If, Cytomegalovirus Virus	LKQ	2	Manufacturer	accessdata.fda.gov
Antigen, Cf (Including Cf Control), Cytomegalovirus	GQH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antigen, Cf, (Including Cf Control), Varicella-Zoster	GQW	2	Manufacturer	accessdata.fda.gov
Antigen, Ebv, Capsid	MCD	1	Manufacturer	accessdata.fda.gov
Antigens, If, Toxoplasma Gondii	GLZ	2	Manufacturer	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control	DBJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee	GQC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Control For Nontreponemal Tests	GMP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Fluorescent, Chlamydia Spp.	LKI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Fluorescent, Herpesvirus Hominis 1,2	GQL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antiserum, Fluorescent, Epstein-Barr Virus	JRY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	DBE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg	MYL	3	Manufacturer	accessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	MYM	3	Manufacturer	accessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)	MVM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	PIV	2	Manufacturer	accessdata.fda.gov
Chamber, Slide Culture	KIY	1	Manufacturer	accessdata.fda.gov
Column Chromatography & Color Development, Hydroxyproline	JMM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Complement C1q, Antigen, Antiserum, Control	DAK	2	Manufacturer	accessdata.fda.gov
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	MVJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps Virus	LJY	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	LJZ	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	LJB	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	LFY	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	MXJ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	MYF	2	Manufacturer	accessdata.fda.gov
Epstein-Barr Virus, Other	LSE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fixative, Alcohol Containing	LDZ	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Manufacturer	accessdata.fda.gov
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	DBL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2	OPM	2	Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer	accessdata.fda.gov
Reagent, Rickettsia Serological	LSQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	LHL	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System, Test, Systemic Lupus Erythematosus	DHC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Antigen, Nuclear, Epstein-Barr Virus	LLM	1	Manufacturer	accessdata.fda.gov
Thyroglobulin, Antigen, Antiserum, Control	DDC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 112.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2026	K261466	Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM	MOB	Substantially Equivalent	Zeus Scientific	accessdata.fda.gov
May 8, 2026	K250814	Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB	OBE	Substantially Equivalent	Zeus Scientific	accessdata.fda.gov
October 22, 2025	K250666	Alegria Flash CTD Screen	LLL	Substantially Equivalent	Zeus Scientific	accessdata.fda.gov
September 19, 2025	K250408	Alegria Flash ENA Screen	LLL	Substantially Equivalent	Zeus Scientific	accessdata.fda.gov
May 7, 2025	K243776	Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)	MOB	Substantially Equivalent	Zeus Scientific	accessdata.fda.gov
April 29, 2022	K201956	Zeus IFA ANA HEp-2 Test System, Zeus dIFine	DHN	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 26, 2012	K113397	ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM	LSR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 12, 2011	K102425	ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 20, 2011	K103603	ZEUS ELISA HSV GG-2 IGG TEST SYSTEM	MYF	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 26, 2011	K103363	ZEUS ELISA HSV GC-I IGG TEST SYSTEM	MXJ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 10, 2011	K102283	ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM	LIP	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
October 1, 2010	K093837	ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM	LIP	Substantially Equivalent	Zeus Scientific, Inc. (Zeus)	accessdata.fda.gov
July 16, 2010	K093784	ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM	OPM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 30, 2008	K072178	ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM	MXJ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 6, 2007	K071219	ATHENA MULTI-LYTE GBM TEST SYSTEM	MVJ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 5, 2007	K070317	ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM	LFY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 21, 2007	K063186	ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM	LFX	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 5, 2005	K051484	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.	LFY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 29, 2005	K042118	ATHENA MULTI-LYTE EBV IGG TEST SYSTEM	JRY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 12, 2005	K042092	ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM	LJN	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
October 8, 2004	K042416	ATHENA MULTI-LYTE ANA-II TEST SYSTEM	LKJ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 5, 2004	K040111	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 22, 2004	K033977	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM	JZO	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 27, 2004	K033802	ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM	DHR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 18, 2000	K000363	MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM	DDC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 22, 1999	K992587	EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM	LSE	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
November 1, 1999	K993034	MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD	MVM	Substantially Equivalent	Medica, Inc.	accessdata.fda.gov
August 12, 1999	K991820	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI	LYR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 25, 1999	K991610	ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.	DDC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 17, 1999	K991179	ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM	DDC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 21, 1999	K990915	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY	DHN	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
March 26, 1999	K990207	GLIADIN IGA ELISA TEST SYSTEM	MST	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 26, 1999	K990204	GLIADIN IGG ELISA TEST SYSTEM	MST	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 18, 1999	K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	LGC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
August 21, 1998	K981120	ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA	LSE	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 30, 1998	K980821	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM	LYR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 6, 1998	K980638	ADI SYPHILIS RPR LIQUID CONTROLS	GMP	Substantially Equivalent	Ampcor Diagnostics, Inc.	accessdata.fda.gov
June 2, 1998	K981021	ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 2, 1998	K981014	ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 18, 1998	K981020	ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 17, 1998	K972873	IMMUSTRIP HAMA IGG	DAK	Substantially Equivalent	Immunomedics, Inc.	accessdata.fda.gov
August 20, 1997	K971503	MYCOPLASMA IGM ELISA TEST SYSTEM	LJZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 18, 1997	K970149	LEGIONELLA ELISA TEST SYSTEM	LHL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 16, 1997	K970150	MYCOPLASMA IGG ELISA TEST SYSTEM	LJZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964449	ANCA SCREEN ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964448	PROTEINASE-3 IGG ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964446	MYELOPEROXIDASE ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 20, 1997	K970198	IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES	DHN	Substantially Equivalent	Scimedx Corp.	accessdata.fda.gov
September 30, 1996	K962360	IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES	MOB	Substantially Equivalent	Scimedx Corp.	accessdata.fda.gov
July 24, 1996	K961012	VZV IGG ELISA TEST SYSTEM	LFY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 18, 1996	K961204	MUMPS IGG TEST	LJY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 8, 1996	K961277	RF IGM ELISA TEST SYSTEM	DHR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1996	K953495	EIA KIT FOR THE DETECTION OF GBM ANTIBODIES	DBL	Substantially Equivalent	Scimedx Corp.	accessdata.fda.gov
September 25, 1995	K944449	EBV-VCA IGM ELISA TEST STSTEM	LSE	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 5, 1995	K932742	EBNA IGG ELISA TEST SYSTEM	LLM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 28, 1994	K940362	ANA SCREEN ELISA TEST SYSTEM	LLL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 10, 1994	K941409	ENA PROFILE-6 ELISA TEST SYSTEM	LJM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 10, 1994	K941014	ENA SCREEN ELISA TEST SYSTEM	LJM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 15, 1993	K933267	AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM	LJM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 23, 1993	K924882	TOXOPLASMA IGM IFA TEST SYSTEM	GLZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
January 11, 1993	K924091	EBV-VCA IGG ELISA TEST SYSTEM	MCD	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 15, 1992	K924197	ZORBA(TM) IGG REMOVAL REAGENT	DEW	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 22, 1992	K914028	RUBELLA IGM ELISA TEST SYSTEM	LFX	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 19, 1992	K914953	IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY	LKI	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
December 18, 1991	K913787	TOXOPLASMA IGM ELISA TEST SYSTEM	LGD	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
November 7, 1991	K905608	INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1	GQL	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
July 9, 1990	K902237	MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT	DBL	Substantially Equivalent	Medica Corp.	accessdata.fda.gov
May 2, 1990	K900196	LYME IGM ELISA TEST SYSTEM	LSR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 26, 1990	K900743	CMV-IGM IFA TEST SYSTEM	LKQ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 16, 1990	K900974	INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.	JRY	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
February 27, 1990	K896355	CMV IGM ELISA TEST SYSTEM	LFZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
January 2, 1990	K897025	ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM	DHN	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 13, 1989	K895292	LYME IGG ELISA TEST SYSTEM	LSR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
August 3, 1989	K891783	RUBELLA ELISA TEST SYSTEM	LFX	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 14, 1989	K891781	TOXO ELISA TEST SYSTEM	LGD	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 20, 1989	K891782	HSV-2 ELISA TEST SYSTEM	GQL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 20, 1989	K891162	HSV-1 ELISA TEST SYSTEM	GQL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 2, 1989	K891081	CMV ELISA TEST SYSTEM	LFZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 2, 1989	K885317	LYME ELISA TEST SYSTEM	LSR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 15, 1988	K882447	EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES	LSE	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 15, 1988	K882440	EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST	LLM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
December 5, 1988	K882835	INDIRECT FLUORESCENT ASSAY FOR (HCMV)	GQH	Substantially Equivalent	Stellar Bio Systems, Inc.	accessdata.fda.gov
March 30, 1988	K880477	RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	GMQ	Substantially Equivalent	Ampcor, Inc.	accessdata.fda.gov
March 30, 1988	K880165	TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	GMQ	Substantially Equivalent	Ampcor, Inc.	accessdata.fda.gov
August 25, 1987	K871246	IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI	LSR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 19, 1985	K841434	VARICELLA-ZOSTER(IGG) IFA TEST	GQW	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
October 22, 1984	K843343	MEDICA IIF-ANTI-THYROID ANTIBODY TEST	JZO	Substantially Equivalent	Medical Diagnostics, Ca.	accessdata.fda.gov
December 27, 1983	K833014	EBV-VCA-IGM IFA TEST SYSTEM	LJN	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
October 14, 1983	K832896	LEGIONELLA INDIRECT FLUORESCENT ANTIBOD	LHL	Substantially Equivalent	Biodan Medical Systems, Ltd.	accessdata.fda.gov
June 22, 1983	K831026	INDIRECT FLUORESCENT ANTIBODY REAGENTS	LHL	Substantially Equivalent	Zeus Technologies	accessdata.fda.gov
June 15, 1983	K831358	AUTOANTIBODY SCREEN TEST SYSTEM	DBM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 4, 1983	K831100	MEDICA IIF-MULTIPLE ANTIBODY TEST KIT	DBM	Substantially Equivalent	Medical Diagnostics, Ca.	accessdata.fda.gov
February 16, 1983	K822859	DIRECT FA CONJUGATE FOR LEGIONELLA SPP	LHL	Substantially Equivalent	Zeus Technologies	accessdata.fda.gov
September 21, 1982	K822066	LEGIONELLA PNEUMOPHILA	LHL	Substantially Equivalent	Biodan Medical Systems, Ltd.	accessdata.fda.gov
September 16, 1981	K811671	CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM	GQH	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
September 1, 1981	K812085	HERPES VIRUS HOMINIS ANTIBODY TEST SYS.	GQL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
August 12, 1981	K811261	ANTI-SKIN ANTIBODY TEST SYSTEM	DBL	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 27, 1981	K811262	EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI	JRY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
September 24, 1979	K791571	TOXOPLASMA ANTIBODY TEST SYSTEM	GLZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 30, 1979	K790759	IIF-APCA TEST KIT	DBJ	Substantially Equivalent	Medica Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 19, 2017	P150045	ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM	MYL	0	September 19, 2017	accessdata.fda.gov
September 19, 2017	P150042	ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM	MYM	0	September 19, 2017	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 31, 2023	93514	Class II	Ongoing	ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M	The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.	accessdata.fda.gov
August 12, 2019	86364	Class II	Terminated	ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age whe	FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.	accessdata.fda.gov
July 22, 2019	83426	Class II	Terminated	Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM	Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for	accessdata.fda.gov
March 8, 2012	61646	Not yet classified	Terminated	AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test Sys	Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps.	accessdata.fda.gov
August 19, 2008	49438	Not yet classified	Terminated	Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 0	The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.	accessdata.fda.gov
August 30, 2004	29963	Not yet classified	Terminated	Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution,	During packaging, Lyme plates were packaged in this kit in error.	accessdata.fda.gov
June 12, 2003	26589	Not yet classified	Terminated	Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.	The Calibrator included within the kit may be losing reactivity.	accessdata.fda.gov
November 9, 2001	26516	Not yet classified	Terminated	Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.	Calibrator C not meeting its optical density specification.	accessdata.fda.gov
June 22, 2001	26578	Not yet classified	Terminated	Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.	Bacterial contamination of the high positive control.	accessdata.fda.gov
March 19, 2001	26402	Not yet classified	Terminated	Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnosti	Mix-up between low positive and negative controls.	accessdata.fda.gov
February 24, 2000	26562	Not yet classified	Terminated	Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., S	The high positive control/low positive standard ratio recovering too low.	accessdata.fda.gov

Compare with other makers

Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.