Zeus Scientific, Inc.
Medical device manufacturer in Branchburg, NJ.
142510(k) clearances
3PMA approvals
6recalls
Device types
- LSR Reagent, Borrelia Serological Reagent 13
- LLL Extractable Antinuclear Antibody, Antigen… 9
- MID System, Test, Anticardiolipin Immunological 9
- MOB Test System, Antineutrophil Cytoplasmic… 9
- LJM Antinuclear Antibody (Enzyme-Labeled)… 6
- DHN Antinuclear Antibody, Indirect… 6
- GQL Antisera, Fluorescent, Herpesvirus Hominis… 5
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 5
- LFZ Enzyme Linked Immunoabsorbent Assay… 5
- LSE Epstein-Barr Virus, Other 5
- MST Antibodies, Gliadin 4
- LFY Enzyme Linked Immunoabsorbent Assay… 4
- LGD Enzyme Linked Immunoabsorbent Assay… 4
- DHR System, Test, Rheumatoid Factor 3
- DDC Thyroglobulin, Antigen, Antiserum, Control 3
- LJZ Enzyme Linked Immunoabsorbent Assay… 3
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 3
- LKJ Antinuclear Antibody, Antigen, Control 3
- JZO System, Test, Thyroid Autoantibody 3
- LJN Antibody Igm, If, Epstein-Barr Virus 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K113397 | Zeus Elisa Borrelia VLSE-1/PEPC10 Igg/Igm Test SystemLSR · Traditional | 07/26/2012SE |
| K102425 | Zeus Elisa Cardiolipin Igg/Igm/Iga Test SystemMID · Traditional | 12/12/2011SE |
| K103603 | Zeus Elisa HSV GG-2 Igg Test SystemMYF · Traditional | 05/20/2011SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | 04/26/2011SE |
| K102283 | Zeus Scientific, Inc. Treponema Pallidum Igg Test SystemLIP · Traditional | 02/10/2011SE |
| K093784 | Athena Multi-Lyte Torch Igg Plus Test SystemOPM · Traditional | 07/16/2010SE |
| K100728 | Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test SystemLSR · Traditional | 07/06/2010SE |
| K072178 | Athena Multi-Lyte HSV 1 & 2 Igg Test SystemMXJ · Traditional | 05/30/2008SE |
| K071219 | Athena Multi-Lyte GBM Test SystemMVJ · Traditional | 12/06/2007SE |
| K070317 | Zeus Scientific, Inc VZV Igm Elisa Test SystemLFY · Traditional | 07/05/2007SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | 03/21/2007SE |
| K051484 | Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.LFY · Traditional | 12/05/2005SE |
| K042118 | Athena Multi-Lyte Ebv Igg Test SystemJRY · Traditional | 04/29/2005SE |
| K042092 | Athena Multi-Lyte Ebv Vca Igm Test SystemLJN · Traditional | 04/12/2005SE |
| K042416 | Athena Multi-Lyte Ana-Ii Test SystemLKJ · Special | 10/08/2004SE |
| K040111 | Zeus Scientific, Inc., Athena Multi-Lyte MPO/PR3 Igg Test SystemMOB · Traditional | 04/05/2004SE |
| K033977 | Zeus Scientific, Inc., Athena Multi-Lyte Tpo/Tg Igg Test SystemJZO · Traditional | 03/22/2004SE |
| K033802 | Athena Multi-Lite Rheumatoid Factor Igm Test SystemDHR · Traditional | 02/27/2004SE |
| K021103 | Modification to Zeus Scientific's Athena Multi-Lyte Ana Test SystemLKJ · Special | 04/24/2002SE |
| K011244 | Zeus Scientific, Inc. Athena Multi-Lyte Ana Test SystemLKJ · Traditional | 12/10/2001SE |
| K001393 | The Aptus, Automated Application of the Gliadin Iga Elisa Test System. an Enzyme Linked…MST · Traditional | 06/07/2000SE |
| K000880 | The Aptus (Automated Application of the Tpo Igg Elisa Test System. an Enzyme Linked…LJM · Traditional | 05/22/2000SE |
| K000879 | The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked…LJM · Traditional | 05/22/2000SE |
| K000363 | Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Special | 02/18/2000SE |
| K000362 | Modification to Zeus Scientific, Inc., Tpo Igg Elisa Test SystemJZO · Special | 02/18/2000SE |
| K993250 | The Aptus (Automated) Application of the Gliadin Igg Elisa Test System.MST · Traditional | 11/12/1999SE |
| K992166 | The Aptus (Automated) Application of the HSV 1/2 Igm Elisa Test System. an Enzyme Linked…LGC · Traditional | 09/03/1999SE |
| K991185 | Borrelia Burgdorferi Igm Western Blot Test SystemLSR · Traditional | 09/03/1999SE |
| K991180 | Borrelia Burgdorferi Igg Western Blot Test SystemLSR · Traditional | 09/03/1999SE |
| K991820 | Helicobacter Pylori Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay…LYR · Traditional | 08/12/1999SE |
| K984180 | The Aptus (Automated) Application of the Rubella Igm Elisa Test SystemLFX · Traditional | 07/20/1999SE |
| K991610 | Zeus Scientific Inc., Tpo Igg Elisa Test System.DDC · Traditional | 06/25/1999SE |
| K991179 | Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Traditional | 06/17/1999SE |
| K984135 | The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | 05/26/1999SE |
| K984120 | The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | 05/26/1999SE |
| K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked…LFX · Traditional | 05/26/1999SE |
| K990207 | Gliadin Iga Elisa Test SystemMST · Traditional | 03/26/1999SE |
| K990204 | Gliadin Igg Elisa Test SystemMST · Traditional | 03/26/1999SE |
| K984138 | Aptus (Automated) Application for the B. Burgdorferi Antibody Elisa Test SystemLSR · Traditional | 03/23/1999SE |
| K983656 | HSV-1 And/Or -2 Igm Elisa Test SystemLGC · Traditional | 03/18/1999SE |
| K984317 | The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme…LGD · Traditional | 01/22/1999SE |
| K984181 | The Aptus (Automated) Application of the VZV Igg Elisa Test SystemLFY · Traditional | 01/22/1999SE |
| K984170 | The Aptus (Automated) Application of the Toxoplasma Igm Elisa Test SystemLGD · Traditional | 01/19/1999SE |
| K984516 | The Aptus (Automated) Application of the Mpo Elisa Test System. an Enzyme Linked…MOB · Traditional | 01/11/1999SE |
| K984153 | The Aptus (Automated) Application of the Mycoplasma Igm Elisa Test System.LJZ · Traditional | 01/11/1999SE |
| K984139 | The Aptus (Automated) Application of the CMV Igg Elisa Test System. an Enzyme Linked…LFZ · Traditional | 01/11/1999SE |
| K984133 | The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked…LLM · Traditional | 01/11/1999SE |
| K984126 | The Aptus (Automated) Application of the Ebv-Vca Igg Elisa Test System. an Enzyme Linked…MCD · Traditional | 01/11/1999SE |
| K984123 | The Aptus (Automated) Application of the Legionella Igg/A/M (Elisa) Test System. an…LHL · Traditional | 01/11/1999SE |
| K984173 | The Aptus (Automated) Application of the Anti-Cardiolipin Iga Elisa Test SystemMID · Traditional | 12/22/1998SE |
| K984347 | The Aptus (Automated) Application of the Anti-Cardiolipin Igg Elisa Test System. an…MID · Traditional | 12/17/1998SE |
| K984315 | The Aptus (Automated) Application of the PR-3 Elisa Test System. an Aneyme Linked…MOB · Traditional | 12/17/1998SE |
| K984175 | The Aptus (Automated) Application of the Anti-Cardiolipin Igm Elisa Test SystemMID · Traditional | 12/17/1998SE |
| K983803 | The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked…LFZ · Traditional | 12/14/1998SE |
| K983801 | The Aptus (Automated) Application of the Ebv-Vca Igm Elisa Test System. an Enzyme Linked…LSE · Traditional | 12/10/1998SE |
| K983804 | The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked…LSE · Traditional | 12/08/1998SE |
| K984034 | The Aptus (Automated) Application of the Anca Screen Elisa Test System. an Enzyme Linked…MOB · Traditional | 11/30/1998SE |
| K983465 | The Aptus (Automated) Application of the Sm/Rnp Elisa Test System. an Enzyme Linked…LKO · Traditional | 11/18/1998SE |
| K983464 | The Aptus (Automated) Application of the JO-1 Elisa Test System. an Enzyme Linked…LLL · Traditional | 11/18/1998SE |
| K983426 | The Aptus (Automated) Application of the Ssa Elisa Test System. an Enzyme Linked…LLL · Traditional | 11/18/1998SE |
| K983425 | The Aptus (Automated)Application of the SSB Elisa Test System. an Enzyme Linked…LLL · Traditional | 11/18/1998SE |
| K983423 | The Aptus (Automated) Application of the SCL-70 Elisa Test System. an Enzyme Linked…LLL · Traditional | 11/18/1998SE |
| K983422 | The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent…LRM · Traditional | 11/18/1998SE |
| K983420 | The Aptus(Automated)Application of the SM Elisa Test System.An Enzyme Link Immunosorbent…LKP · Traditional | 11/18/1998SE |
| K983418 | The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an…DHR · Traditional | 11/18/1998SE |
| K983378 | The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked…LJM · Traditional | 11/18/1998SE |
| K983376 | The Aptus (Automated) Applicaton of the Ena Screen Elisa Test System. an Enzyme Linked…LLL · Traditional | 11/18/1998SE |
| K981120 | Zeus Scientific Inc., Anti-Ebv Ea Igg ElisaLSE · Traditional | 08/21/1998SE |
| K980821 | Helicobacter Pylori Igg Elisa Test SystemLYR · Traditional | 07/30/1998SE |
| K981021 | Zeus Anti-Cardiolipin Igm Test SystemMID · Traditional | 06/02/1998SE |
| K981014 | Zeus Scientific, Inc. Anti-Cardiolipin Igg Elisa Test SystemMID · Traditional | 06/02/1998SE |
| K981020 | Zeus Anti-Cardiolipin Igs Elisa Test SystemMID · Traditional | 05/18/1998SE |
| K973196 | Zeus Scientific, Inc., Anti-Cardiolipin Iga Elisa ReagentsMID · Traditional | 10/29/1997SE |
| K971503 | Mycoplasma Igm Elisa Test SystemLJZ · Traditional | 08/20/1997SE |
| K971784 | Zeus Scientific, Inc., Anticardiolipin Igg/Igm Elisa Test SystemMID · Traditional | 07/23/1997SE |
| K970149 | Legionella Elisa Test SystemLHL · Traditional | 06/18/1997SE |
| K970150 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | 06/16/1997SE |
| K964449 | Anca Screen Elisa Test SystemMOB · Traditional | 04/10/1997SE |
| K964448 | PROTEINASE-3 Igg Elisa Test SystemMOB · Traditional | 04/10/1997SE |
| K964446 | Myeloperoxidase Elisa Test SystemMOB · Traditional | 04/10/1997SE |
| K961012 | VZV Igg Elisa Test SystemLFY · Traditional | 07/24/1996SE |
| K961204 | Mumps Igg TestLJY · Traditional | 07/18/1996SE |
| K961277 | RF Igm Elisa Test SystemDHR · Traditional | 05/08/1996SE |
| K946373 | Mycoplasma Slurry and Mycoplasma Crowntitre Ifa Test SystemGRZ · Traditional | 02/07/1996SE |
| K944449 | Ebv-Vca Igm Elisa Test StstemLSE · Traditional | 09/25/1995SE |
| K944417 | Zeua MycoplasmaGRZ · Traditional | 08/01/1995SE |
| K932742 | Ebna Igg Elisa Test SystemLLM · Traditional | 05/05/1995SE |
| K940362 | Ana Screen Elisa Test SystemLLL · Traditional | 07/28/1994SE |
| K941409 | Ena PROFILE-6 Elisa Test SystemLJM · Traditional | 06/10/1994SE |
| K941014 | Ena Screen Elisa Test SystemLJM · Traditional | 06/10/1994SE |
| K933267 | Autoantibody PROFILE-6 Elisa Test SystemLJM · Traditional | 12/15/1993SE |
| K924096 | CMV Elisa Test SystemLFZ · Traditional | 04/02/1993SE |
| K924882 | Toxoplasma Igm Ifa Test SystemGLZ · Traditional | 03/23/1993SE |
| K924091 | Ebv-Vca Igg Elisa Test SystemMCD · Traditional | 01/11/1993SE |
| K924197 | Zorba(Tm) Igg Removal ReagentDEW · Traditional | 12/15/1992SE |
| K914028 | Rubella Igm Elisa Test SystemLFX · Traditional | 04/22/1992SE |
| K913787 | Toxoplasma Igm Elisa Test SystemLGD · Traditional | 12/18/1991SE |
| K900196 | Lyme Igm Elisa Test SystemLSR · Traditional | 05/02/1990SE |
| K900743 | Cmv-Igm Ifa Test SystemLKQ · Traditional | 04/26/1990SE |
| K896355 | CMV Igm Elisa Test SystemLFZ · Traditional | 02/27/1990SE |
| K897025 | Antinuclear Antibody (Ana) Test SystemDHN · Traditional | 01/02/1990SE |
| K895292 | Lyme Igg Elisa Test SystemLSR · Traditional | 12/13/1989SE |
| K891783 | Rubella Elisa Test SystemLFX · Traditional | 08/03/1989SE |
| K891781 | Toxo Elisa Test SystemLGD · Traditional | 07/14/1989SE |
| K891782 | HSV-2 Elisa Test SystemGQL · Traditional | 06/20/1989SE |
| K891162 | HSV-1 Elisa Test SystemGQL · Traditional | 06/20/1989SE |
| K891081 | CMV Elisa Test SystemLFZ · Traditional | 06/02/1989SE |
| K885317 | Lyme Elisa Test SystemLSR · Traditional | 03/02/1989SE |
| K882447 | Epstein-Barr Virus Early Antigen (Ea) Antibody TesLSE · Traditional | 12/15/1988SE |
| K882440 | Epstein-Barr Virus Nuclear Antigen Antibody TestLLM · Traditional | 12/15/1988SE |
| K871246 | Ifa Test for Antibodies to Borrelia BurgdorferiLSR · Traditional | 08/25/1987SE |
| K841434 | Varicella-Zoster(Igg) Ifa TestGQW · Traditional | 04/19/1985SE |
| K840221 | Extractable Nuclear Antigen AssayLLL · Traditional | 05/22/1984SE |
| K833014 | Ebv-Vca-Igm Ifa Test SystemLJN · Traditional | 12/27/1983SE |
| K831358 | Autoantibody Screen Test SystemDBM · Traditional | 06/15/1983SE |
| K821060 | Fluoro-Cep · Traditional | 06/22/1982SE |
| K811671 | Cytomegalovirus Antibody Test SystemGQH · Traditional | 09/16/1981SE |
| K812085 | Herpes Virus Hominis Antibody Test Sys.GQL · Traditional | 09/01/1981SE |
| K811261 | Anti-Skin Antibody Test SystemDBL · Traditional | 08/12/1981SE |
| K811262 | Epstein-Barr Virus Capsid Antigen AntiJRY · Traditional | 05/27/1981SE |
| K791571 | Toxoplasma Antibody Test SystemGLZ · Traditional | 09/24/1979SE |
| K781516 | Test System Tissue Cell Culture SlideKIY · Traditional | 09/27/1978SE |
| K781403 | Fta-Abs Test SystemGMS · Traditional | 08/21/1978SE |
| K780178 | Test Sys. for Ndna Antibody Determ.DHN · Traditional | 02/13/1978SE |
| K780161 | Immunoperoxidase Test Sys. for Ana SeterDHN · Traditional | 02/07/1978SE |
| K761138 | Fa Tissue Fixative & Wash SetLDZ · Traditional | 01/06/1978SE |
| K760209 | Acid, Native-Deoxyribonucleic, IvdpDHN · Traditional | 07/26/1976SE |
| K760156 | Test, (Ivdp) Smoothmuscle AntibodyDBE · Traditional | 07/20/1976SE |
| K760155 | Test, (Ivdp) Mitochondrial AntibodyDBM · Traditional | 07/20/1976SE |
| K760154 | Test, (Ivdp) Thyroid AntibodyJZO · Traditional | 07/20/1976SE |
| K760153 | Test, (Ivdp) Antinuclear AntibodyDHN · Traditional | 07/20/1976SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0603-2024 Class II | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701GThe organization completed a product improvement process to the conjugate found within the certain ELISA… | 10/31/2023Open, Classified |
| Z-0602-2024 Class II | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701MThe organization completed a product improvement process to the conjugate found within the certain ELISA… | 10/31/2023Open, Classified |
| Z-3026-2020 Class II | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended…FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA… | 08/12/2019Terminated |
| Z-2494-2019 Class II | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS…Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in… | 07/22/2019Terminated |
| Z-1500-2012 | AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended…Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results… | 03/08/2012Terminated |
| Z-1089-2009 | Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual…The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator… | 08/19/2008Terminated |