Is this your brand? Sign in to claim ownership.

ZEUS SCIENTIFIC, INC.

United States·US-MF-000026845

Last updated May 23, 2026

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 7 of 7

Device	Model / Reference	Registries	Class	Status
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System	K190907	FDA 510(k)	Class II	Active
Epstein-Barr Virus Nuclear Antigen Antibody Test	K882440	FDA 510(k)	Class I	Active
Zeus Elisa Cardiolipin Igg/Igm/Iga Test System	K102425	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Cmv Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K983803	FDA 510(k)	Class II	Active
Rubella Elisa Test System	K891783	FDA 510(k)	Class II	Active
The Aptus(automated) Application Of The Hsv-2 Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For Th	K984120	FDA 510(k)	Class II	Active
Cmv-Igm Ifa Test System	K900743	FDA 510(k)	Class II	Active
Athena Multi-Lyte Torch Igg Plus Test System	K093784	FDA 510(k)	Class II	Active
Zeua Mycoplasma	K944417	FDA 510(k)	Class I	Active
Aptus (automated) Application For The B. Burgdorferi Antibody Elisa Test System	K984138	FDA 510(k)	Class II	Active
The Aptus (automated)application Of The Ssb Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The Det	K983425	FDA 510(k)	Class II	Active
Test, (ivdp) Antinuclear Antibody	K760153	FDA 510(k)	Class II	Active
Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System	K011244	FDA 510(k)	Class II	Active
Lyme Elisa Test System	K885317	FDA 510(k)	Class II	Active
Proteinase-3 Igg Elisa Test System	K964448	FDA 510(k)	Class II	Active
The Aptus, Automated Application Of The Gliadin Iga Elisa Test System. An Enzyme Linked Immunosorbent Assay, Elisa For	K001393	FDA 510(k)	Class II	Active
Test, (ivdp) Thyroid Antibody	K760154	FDA 510(k)	Class II	Active
Zeus Elisa Hsv Gg-2 Igg Test System	K103603	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Ana Screen Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For.	K983378	FDA 510(k)	Class II	Active
Helicobacter Pylori Igg Elisa Test System	K980821	FDA 510(k)	Class I	Active
Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test System	K991179	FDA 510(k)	Class II	Active
Zeus Anti-Cardiolipin Igm Test System	K981021	FDA 510(k)	Class II	Active
The Aptus (automated) Applicaton Of The Ena Screen Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For S	K983376	FDA 510(k)	Class II	Active
Herpes Virus Hominis Antibody Test Sys.	K812085	FDA 510(k)	Class II	Active
Acid, Native-Deoxyribonucleic, Ivdp	K760209	FDA 510(k)	Class II	Active
Autoantibody Profile-6 Elisa Test System	K933267	FDA 510(k)	Class II	Active
The Aptus(automated)application Of The Sm Elisa Test System.an Enzyme Link Immunosorbent Assay(elisa)for The Detectioo	K983420	FDA 510(k)	Class II	Active
Test, (ivdp) Mitochondrial Antibody	K760155	FDA 510(k)	Class II	Active
Cytomegalovirus Antibody Test System	K811671	FDA 510(k)	Class II	Active
Ebv-Vca Igg Elisa Test System	K924091	FDA 510(k)	Class I	Active
The Aptus (automated) Application Of The Anca Screen Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For	K984034	FDA 510(k)	Class II	Active
Zeus Elisa Borrelia Vlse-1/Pepc10 Igg/Igm Test System	K113397	FDA 510(k)	Class II	Active
Immunoperoxidase Test Sys. For Ana Seter	K780161	FDA 510(k)	Class II	Active
Toxoplasma Igm Ifa Test System	K924882	FDA 510(k)	Class II	Active
Zeus Scientific Inc., Anti-Ebv Ea Igg Elisa	K981120	FDA 510(k)	Class I	Active
Zeus Elisa Parvovirus B19 Igm Test System	P150042	FDA PMA	Class III	Active
Fluoro-Cep (r) Progesterone	K821060	FDA PMA	Class III	Active
Zeus Elisa Parvovirus B19 Igg Test System	P150045	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

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.