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ZEUS SCIENTIFIC, INC.

United States·US-MF-000026845

Last updated May 23, 2026

What ZEUS SCIENTIFIC, INC. makes

Zeus Scientific, Inc. manufactures in vitro diagnostic (IVD) test kits for detecting specific antibodies and biomarkers in blood or serum. These include enzyme immunoassays (EIA) for Borrelia burgdorferi, Helicobacter pylori, herpes simplex viruses (HSV1/HSV2), and collagen-related markers, as well as fluorescent immunoassays for systemic lupus erythematosus (SLE)-associated antibodies, Epstein-Barr virus (EBV), and varicella-zoster virus (VZV). The portfolio also covers tests for autoimmune markers like anticardiolipin antibodies and anti-neutrophil cytoplasmic antibodies (ANCA).

The company’s products are regulated under FDA Class I and Class II devices, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These tests are designed for laboratory use in diagnosing infectious diseases, autoimmune conditions, and other medical evaluations. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 200 Evans Way, Branchburg, United States
Website: www.zeusscientific.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-908-526-3744
PRRC Contact: Kevin Bielski
EUDAMED SRN: US-MF-000026845
FDA FEI Number: —
DUNS Number: 080953946

Catalogue (338)

Page 5 of 7

Device	Model / Reference	Registries	Class	Status
Zeus Scientific, Inc., Athena Multi-Lyte Mmrv Igg Test System.	K051484	FDA 510(k)	Class II	Active
The Aptus (automated) Applications Of The Ds Dna Elisa Test System Linked Immunosorbent Assay(elisa)for The Det	K983422	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Mycoplasma Igm Elisa Test System.	K984153	FDA 510(k)	Class I	Active
The Aptus(automated)application Of The Rheumatoid Factor Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay(el	K983418	FDA 510(k)	Class II	Active
Antinuclear Antibody (ana) Test System	K897025	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Anti-Cardiolipin Iga Elisa Test System	K984173	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Tg Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K000879	FDA 510(k)	Class II	Active
Hsv-1 Elisa Test System	K891162	FDA 510(k)	Class II	Active
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System	K191240	FDA 510(k)	Class II	Active
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)	K243776	FDA 510(k)	Class II	Active
Vzv Igg Elisa Test System	K961012	FDA 510(k)	Class II	Active
Athena Multi-Lyte Ebv Igg Test System	K042118	FDA 510(k)	Class I	Active
The Aptus (automated) Application Of The Cmv Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K984139	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Ebna Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For Th	K984133	FDA 510(k)	Class I	Active
The Aptus (automated) Application Of The Ebv-Ea Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For	K983804	FDA 510(k)	Class I	Active
The Aptus (automated) Application Of The Pr-3 Elisa Test System. An Aneyme Linked Immunosorbent Assay (elisa) For The De	K984315	FDA 510(k)	Class II	Active
Ana Screen Elisa Test System	K940362	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Ebv-Vca Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For	K984126	FDA 510(k)	Class I	Active
Mumps Igg Test	K961204	FDA 510(k)	Class I	Active
Athena Multi-Lyte Gbm Test System	K071219	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Anti-Cardiolipin Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (f	K984347	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Ssa Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The Dc	K983426	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Mpo Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The Det	K984516	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Jo-1 Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K983464	FDA 510(k)	Class II	Active
Fa Tissue Fixative & Wash Set	K761138	FDA 510(k)	Class I	Active
Cmv Elisa Test System	K891081	FDA 510(k)	Class II	Active
Lyme Igm Elisa Test System	K900196	FDA 510(k)	Class II	Active
Zeus Scientific Inc., Tpo Igg Elisa Test System.	K991610	FDA 510(k)	Class II	Active
Ebna Igg Elisa Test System	K932742	FDA 510(k)	Class I	Active
Zeus Elisa Hsv Gc-I Igg Test System	K103363	FDA 510(k)	Class II	Active
Toxo Elisa Test System	K891781	FDA 510(k)	Class II	Active
Zeus Scientific, Inc., Athena Multi-Lyte Tpo/Tg Igg Test System	K033977	FDA 510(k)	Class II	Active
Zeus Scientific, Inc., Athena Multi-Lyte Mpo/Pr3 Igg Test System	K040111	FDA 510(k)	Class II	Active
Lyme Igg Elisa Test System	K895292	FDA 510(k)	Class II	Active
Zeus Scientific, Inc., Anti-Cardiolipin Iga Elisa Reagents	K973196	FDA 510(k)	Class II	Active
Cmv Igm Elisa Test System	K896355	FDA 510(k)	Class II	Active
Rubella Igm Elisa Test System	K914028	FDA 510(k)	Class II	Active
Zeus IFA ANA HEp-2 Test System, Zeus dIFine	K201956	FDA 510(k)	Class II	Active
Test System Tissue Cell Culture Slide	K781516	FDA 510(k)	Class I	Active
Anca Screen Elisa Test System	K964449	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Legionella Igg/A/M (elisa) Test System. An Enzyme Linked Immunosorbent Assay (e	K984123	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Toxoplasma Igm Elisa Test System	K984170	FDA 510(k)	Class II	Active
Ena Profile-6 Elisa Test System	K941409	FDA 510(k)	Class II	Active
Athena Multi-Lyte Ebv Vca Igm Test System	K042092	FDA 510(k)	Class I	Active
Zeus Scientific, Inc., Anticardiolipin Igg/Igm Elisa Test System	K971784	FDA 510(k)	Class II	Active
Athena Multi-Lyte Rubella Igg Test System	K063186	FDA 510(k)	Class II	Active
Hsv-2 Elisa Test System	K891782	FDA 510(k)	Class II	Active
Helicobacter Pylori Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa)for The Detection Of Igg Antibodi	K991820	FDA 510(k)	Class I	Active
Athena Multi-Lyte Borrelia Vlse-1/Pepc10 Plus Test System	K100728	FDA 510(k)	Class II	Active
Borrelia Burgdorferi Igg Western Blot Test System	K991180	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Zeus Scientific, Inc. has 12 FDA recall records initiated between February 24, 2000, and October 31, 2023. The records reflect a mix of open, classified, and terminated statuses, with reasons including issues such as bacterial contamination, incorrect calibrator values, false positives due to programming errors or reactivity loss, mislabeled controls, and unapproved product modifications. Some recalls involved errors in packaging or labeling, while others cited deviations in optical density specifications or assay performance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 31, 2023	Z-0603-2024	—	open, classified	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.
Oct 31, 2023	Z-0602-2024	—	open, classified	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.
Aug 12, 2019	Z-3026-2020	—	terminated	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.
Jul 22, 2019	Z-2494-2019	—	terminated	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 any patients tested in well H6.
Mar 8, 2012	Z-1500-2012	—	terminated	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.
Aug 19, 2008	Z-1089-2009	—	terminated	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.
Aug 30, 2004	Z-0214-05	—	terminated	During packaging, Lyme plates were packaged in this kit in error.
Jun 12, 2003	Z-1095-03	—	terminated	The Calibrator included within the kit may be losing reactivity.
Nov 9, 2001	Z-1031-03	—	terminated	Calibrator C not meeting its optical density specification.
Jun 22, 2001	Z-1147-03	—	terminated	Bacterial contamination of the high positive control.
Mar 19, 2001	Z-0961-03	—	terminated	Mix-up between low positive and negative controls.
Feb 24, 2000	Z-1065-03	—	terminated	The high positive control/low positive standard ratio recovering too low.