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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 4 of 7

Device	Model / Reference	Registries	Class	Status
ELISA M. pneumoniae IgM Smart Kit Test System	SM3Z17601M	FDA UDI	N/A	Active
ELISA HSV-1 & 2 IgM Test System	9Z9771M	FDA UDI	N/A	Active
IFA FTA-ABS Double Stain Test System	FA7001DS	FDA UDI	N/A	Active
ELISA dsDNA Test System	2Z2881G	FDA UDI	N/A	Active
ELISA H. pylori IgG Smart Kit Test System	SM3Z51021G	FDA UDI	N/A	Active
ELISA M. pneumoniae IgG Smart Kit Test System	SM3Z17601G	FDA UDI	N/A	Active
ELISA ENA Screen Smart Kit Test Sytem	SM2Z2851G	FDA UDI	N/A	Active
ELISA HSV-1 & 2 IgM Smart Kit Test System	SM9Z9771M	FDA UDI	N/A	Active
IFA L. pneumophila Direct FA Test System	FA12001	FDA UDI	N/A	Active
ELISA VZV IgG Bulk Test System	9Z9331GB	FDA UDI	N/A	Active
ELISA VZV IgG Smart Kit Test System	SM9Z9331G	FDA UDI	N/A	Active
ELISA Rubella IgM Test System	9Z9801M	FDA UDI	N/A	Active
ELISA EBNA-1 IgG Test Sytem	9Z9461G	FDA UDI	N/A	Active
AtheNA Multi-Lyte® ToRCH IgG Plus Test System	A81101G	FDA UDI	N/A	Active
ELISA TPO IgG Test System	2Z5051G	FDA UDI	N/A	Active
IFA AAS Rat Kidney/Stomach Tissue Test System	FA3401	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgM Test System	SM9Z7701M	FDA UDI	N/A	Active
Rat Kidney/Stomach/Liver Tissue	FA3402	FDA UDI	N/A	Active
ELISA Borrelia VlsE1/pepC10 IgG/IgM Q Test System	Q3Z9661B	FDA UDI	N/A	Active
ELISA ANA Screen Test System	2Z29001G	FDA UDI	N/A	Active
ELISA RF IgM Smart Kit Test Sytem	SM2Z9291M	FDA UDI	N/A	Active
ELISA Measles IgG Q Test System	Q9Z9271GB	FDA UDI	N/A	Active
IFA HSV-1 IgG Test System	FA9051G	FDA UDI	N/A	Active
IFA CMV IgG Test System	FA9001G	FDA UDI	N/A	Active
IFA ASMA Test System	FA4001	FDA UDI	N/A	Active
ZEUS ELISA Parvovirus B19 IgG Test System	9Z7701G	FDA UDI	N/A	Active
ELISA Gliadin IgA Test System	2Z61001A	FDA UDI	N/A	Active
IFA AAS Rat Kidney/Stomach/Liver Tissue Test System	FA3402	FDA UDI	N/A	Active
ELISA EBV-EA IgG Smart Kit Test System	SM9Z9481G	FDA UDI	N/A	Active
IFA EBV-NA IgG Test System	FA9153	FDA UDI	N/A	Active
ELISA B. burgdorferi IgG Test System	3Z9651G	FDA UDI	N/A	Active
AtheNA Multi-Lyte® TPO/Tg IgG Plus Test System	A51101	FDA UDI	N/A	Active
Rat Kidney/Stomach Tissue	FA3401	FDA UDI	N/A	Active
IFA ANA Rat Liver Tissue Test System	FA2001	FDA UDI	N/A	Active
ELISA EBV-VCA IgM Q Test System	Q9Z9201MB	FDA UDI	N/A	Active
ELISA TPO IgG Smart Kit Test System	SM2Z5051G	FDA UDI	N/A	Active
IFA ATA Test System	FA5001	FDA UDI	N/A	Active
ELISA Measles IgG Bulk Test System	9Z9271GB	FDA UDI	N/A	Active
ELISA VZV IgM Smart Kit Test System	SM9Z9331M	FDA UDI	N/A	Active
ELISA Cardiolipin IgA Smart Kit Test System	SM2Z51051A	FDA UDI	N/A	Active
IFA ANA Hep-2 Bulk Test System	FA2400	FDA UDI	N/A	Active
ZEUS NTx Serum	NTx9021	FDA UDI	Class I	Active
ELISA Mumps IgG Smart Kit Test System	SM9Z9281G	FDA UDI	N/A	Active
AtheNA Multi-Lyte® MMV IgG Plus Test System	A93111G	FDA UDI	N/A	Active
ELISA B. burgdorferi IgM Test System	3Z9651M	FDA UDI	N/A	Active
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB	K250814	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Rubella Igm Elisa Test System	K984180	FDA 510(k)	Class II	Active
Toxoplasma Antibody Test System	K791571	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Vzv Igg Elisa Test System	K984181	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Hsv 1/2 Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For	K992166	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.

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.