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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 3 of 7

Device	Model / Reference	Registries	Class	Status
ELISA ENA Profile-6 Test System	2Z2801G	FDA UDI	N/A	Active
ZORBA IgG Removal Reagent	FA003G	FDA UDI	N/A	Active
ELISA CMV IgG Smart Kit Test System	SM9Z9501G	FDA UDI	N/A	Active
ELISA Measles IgG Test System	9Z9271G	FDA UDI	N/A	Active
IFA HSV-2 IgG Test Sytem	FA9052G	FDA UDI	N/A	Active
ELISA Sm Smart Kit Test System	SM2Z2831G	FDA UDI	N/A	Active
IFA T. gondii IgM Test System	FA8001M	FDA UDI	N/A	Active
ELISA SSB (La) Test System	2Z2821G	FDA UDI	N/A	Active
IFA ANA Hep-2 w/Evans Blue Test System	FA2401EB	FDA UDI	N/A	Active
ELISA dsDNA Test System Smart Kit Test System	SM2Z2881G	FDA UDI	N/A	Active
ELISA VZV IgM Q Test System	Q9Z9331MB	FDA UDI	N/A	Active
ELISA Sm/RNP Smart Kit Test System	SM2Z2841G	FDA UDI	N/A	Active
ELISA B. burgdorferi IgG/IgM Test System	3Z9651	FDA UDI	N/A	Active
IFA ASA Test System	FA6001	FDA UDI	N/A	Active
ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System	3Z9661	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgG Test System	SM9Z7701G	FDA UDI	N/A	Active
ELISA MPO Smart Kit Test System	SM2Z9671G	FDA UDI	N/A	Active
IFA nDNA Test System	FA1001	FDA UDI	N/A	Active
ELISA RF IgM Test Sytem	2Z9291M	FDA UDI	N/A	Active
ELISA Rubella IgG Test System	9Z9801G	FDA UDI	N/A	Active
IFA CMV IgM Test System	FA9001M	FDA UDI	N/A	Active
ELISA Mumps IgG Bulk Test System	9Z9281GB	FDA UDI	N/A	Active
ELISA HSV gG-2 IgG Smart Kit Test System	SM9Z9781G	FDA UDI	N/A	Active
ELISA T. gondii IgG Q Test System	Q8Z8651GB	FDA UDI	N/A	Active
ELISA Cardiolipin IgG Test System	2Z51051G	FDA UDI	N/A	Active
ELISA H. pylori IgG Test System	3Z51021G	FDA UDI	N/A	Active
IFA EBV-EA IgG Test System	FA9152	FDA UDI	N/A	Active
ELISA Rubella IgM Smart Kit Test System	SM9Z9801M	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgM Test System p	9Z7701M	FDA UDI	N/A	Active
ELISA T. gondii IgG Test System	8Z8651G	FDA UDI	N/A	Active
ELISA HAMA IgG Test System	6401	FDA UDI	N/A	Active
IFA EBV-EA IgG Methanol Test System	FA9150ML	FDA UDI	N/A	Active
IFA ANA Hep-2 Test System	FA2401	FDA UDI	N/A	Active
ELISA Cardiolipin IgM Smart Kit Test System	SM2Z51051M	FDA UDI	N/A	Active
ELISA SSA (Ro) Test System	2Z2811G	FDA UDI	N/A	Active
dsDNA (Crithidia l.)	FA1001	FDA UDI	N/A	Active
ELISA PR-3 Smart Kit Test System	SM2Z9691G	FDA UDI	N/A	Active
AtheNA Multi-Lyte® ANA-II Plus Test System	A21101	FDA UDI	N/A	Active
Sebia NTx Serum Test System	XJ9021	FDA UDI	Class I	Active
AtheNA Multi-Lyte® RF IgM Plus Test System	A91101M	FDA UDI	N/A	Active
ELISA EBV-VCA IgM Smart Kit Test System	SM9Z9201M	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgG Test System	9Z7701GB	FDA UDI	N/A	Active
ELISA MPO Test System	2Z9671G	FDA UDI	N/A	Active
ELISA Jo-1 Test System	2Z2871G	FDA UDI	N/A	Active
ELISA EBNA-1 IgG Smart Kit Test Sytem	SM9Z9461G	FDA UDI	N/A	Active
IFA Measles IgG Test System	FA9251G	FDA UDI	N/A	Active
ELISA Gliadin IgA Smart Kit Test System	SM2Z61001A	FDA UDI	N/A	Active
IFA EBV-VCA IgG Test System	FA9151G	FDA UDI	N/A	Active
ELISA HSV gG-2 IgG Test System	9Z9781G	FDA UDI	N/A	Active
ELISA T. gondii IgM Smart Kit Test System	SM8Z8651M	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.