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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 1 of 7

Device	Model / Reference	Registries	Class	Status
ELISA H. pylori IgG Q Test System	Q3Z51021GB	FDA UDI	N/A	Active
AtheNA Multi-Lyte® EBV IgG Plus Test System	A92101G	FDA UDI	N/A	Active
Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)	FA9611-0510	FDA UDI	Class II	Active
IFA EBV-VCA IgM Test System	FA9151M	FDA UDI	N/A	Active
ELISA Gliadin IgG Smart Kit Test System	SM2Z61001G	FDA UDI	N/A	Active
IFA FTA-ABS Titratable Test System	FA7001T	FDA UDI	N/A	Active
ELISA Tg IgG Smart Kit Test System	SM2Z5061G	FDA UDI	N/A	Active
IFA VZV IgG Test System	FA9301	FDA UDI	N/A	Active
ELISA HSV gG-1 IgG Smart Kit Test System	SM9Z9761G	FDA UDI	N/A	Active
ELISA Scl-70 Smart Kit Test System	SM2Z2861G	FDA UDI	N/A	Active
IFA ANA Hep-2 w/Evans Blue Bulk Test System	FA2400EB	FDA UDI	N/A	Active
Q IFA ANA Hep-2 24-Well Test System	Q240241	FDA UDI	N/A	Active
ELISA Tg IgG Test System	2Z5061G	FDA UDI	N/A	Active
ELISA VZV IgG Test System	9Z9331G	FDA UDI	N/A	Active
ELISA Gliadin IgG Test System	2Z61001G	FDA UDI	N/A	Active
ELISA CMV IgG Q Test System	Q9Z9501GB	FDA UDI	N/A	Active
ELISA T. pallidum IgG Test System	3Z7611G	FDA UDI	N/A	Active
ELISA B. burgdorferi IgG/IgM Bulk Test System	3Z9651B	FDA UDI	N/A	Active
ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System	SM3Z9661	FDA UDI	N/A	Active
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)	FA9601-1010	FDA UDI	Class II	Active
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)	A060L	EUDAMEDFDA UDI	Class II	Active
ELISA VZV IgG Q Test System	Q9Z9331GB	FDA UDI	N/A	Active
ANA HEp-2	FA2500A	FDA UDI	N/A	Active
ELISA Scl-70 Test System	2Z2861G	FDA UDI	N/A	Active
ELISA Measles IgG Smart Kit Test System	SM9Z9271G	FDA UDI	N/A	Active
ELISA T. gondii IgM Test System	8Z8651M	FDA UDI	N/A	Active
ELISA ANCA Screen Test System	2Z9681G	FDA UDI	N/A	Active
ZEUS Wash Solution	0103	FDA UDI	N/A	Active
ELISA VZV IgM Test System	9Z9331M	FDA UDI	N/A	Active
ELISA EBV-EA IgG Q Test System	Q9Z9481G	FDA UDI	N/A	Active
AtheNA Multi-Lyte® AIV Plus Test System	A96101	FDA UDI	N/A	Active
ELISA EBV-VCA IgG Smart Kit Test System	SM9Z9201G	FDA UDI	N/A	Active
ELISA H. pylori IgG Bulk Test System	3Z51021GB	FDA UDI	N/A	Active
ELISA T. gondii IgG Smart Kit Test System	SM8Z8651G	FDA UDI	N/A	Active
ELISA SSA (Ro) Smart Kit Test System	SM2Z2811G	FDA UDI	N/A	Active
ELISA CMV IgM Smart Kit Test System	SM9Z9501M	FDA UDI	N/A	Active
ZEUS ELISA VZV IgM 480 Test System	9Z9331MB	FDA UDI	N/A	Active
ZEUS Scientific Tissue Fixative	0102	FDA UDI	N/A	Active
ELISA ENA Screen Test Sytem	2Z2851G	FDA UDI	N/A	Active
Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)	A060PL	EUDAMEDFDA UDI	Class II	Active
ELISA CMV IgG Test System	9Z9501G	FDA UDI	N/A	Active
ELISA EBV-VCA IgG Q Test System	Q9Z9201GB	FDA UDI	N/A	Active
ELISA HSV gG-1 IgG Test System	9Z9761G	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgM Test System	9Z7701MB	FDA UDI	N/A	Active
IFA ANA Mouse Kidney Tissue Test System	FA2201	FDA UDI	N/A	Active
AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System	A92101M	FDA UDI	N/A	Active
ELISA EBV-EA IgG Test System	9Z9481G	FDA UDI	N/A	Active
ELISA HSV-1 IgG Smart Kit Test System	SM9Z9701G	FDA UDI	N/A	Active
ZEUS NTx Urine	NTx9006	FDA UDI	Class I	Active
ELISA Sm Test System	2Z2831G	FDA UDI	N/A	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.

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.