Company ยท US
Zeus Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
142510(k) clearances (2 in 12 months)
12recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 13 |
| MID | System, Test, Anticardiolipin Immunological | 11 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 9 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 9 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 7 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 6 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 6 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 6 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 5 |
| LSE | Epstein-Barr Virus, Other | 5 |
| DHR | System, Test, Rheumatoid Factor | 4 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 4 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 4 |
| MST | Antibodies, Gliadin | 4 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 3 |
| JZO | System, Test, Thyroid Autoantibody | 3 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 3 |
| LKJ | Antinuclear Antibody, Antigen, Control | 3 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 3 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2026 | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM Zeus Scientific | MOB |
| May 8, 2026 | K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB Zeus Scientific | OBE |
| Oct 22, 2025 | K250666 | Alegria Flash CTD Screen Zeus Scientific | LLL |
| Sep 19, 2025 | K250408 | Alegria Flash ENA Screen Zeus Scientific | LLL |
| May 7, 2025 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) Zeus Scientific | MOB |
| Aug 31, 2023 | K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine Zeus Scientific | KTL |
| Jul 13, 2023 | K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit Zeus Scientific | LSR |
| Apr 29, 2022 | K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine Zeus Scientific, Inc. | DHN |
| Jul 29, 2019 | K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System Zeus Scientific, Inc. | LSR |
| Jul 29, 2019 | K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System Zeus Scientific, Inc. | LSR |
| Jul 29, 2019 | K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System Zeus Scientific, Inc. | LSR |
| Jul 26, 2012 | K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM Zeus Scientific, Inc. | LSR |
| Dec 12, 2011 | K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM Zeus Scientific, Inc. | MID |
| May 20, 2011 | K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM Zeus Scientific, Inc. | MYF |
| Apr 26, 2011 | K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM Zeus Scientific, Inc. | MXJ |
| Feb 10, 2011 | K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM Zeus Scientific, Inc. | LIP |
| Jul 16, 2010 | K093784 | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM Zeus Scientific, Inc. | OPM |
| Jul 6, 2010 | K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM Zeus Scientific, Inc. | LSR |
| May 30, 2008 | K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM Zeus Scientific, Inc. | MXJ |
| Dec 6, 2007 | K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM Zeus Scientific, Inc. | MVJ |
| Jul 5, 2007 | K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LFY |
| Mar 21, 2007 | K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM Zeus Scientific, Inc. | LFX |
| Dec 5, 2005 | K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. Zeus Scientific, Inc. | LFY |
| Apr 29, 2005 | K042118 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM Zeus Scientific, Inc. | JRY |
| Apr 12, 2005 | K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM Zeus Scientific, Inc. | LJN |
| Oct 8, 2004 | K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Apr 5, 2004 | K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM Zeus Scientific, Inc. | MOB |
| Mar 22, 2004 | K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM Zeus Scientific, Inc. | JZO |
| Feb 27, 2004 | K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM Zeus Scientific, Inc. | DHR |
| Apr 24, 2002 | K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Dec 10, 2001 | K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. | LKJ |
| Jun 7, 2000 | K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR Zeus Scientific, Inc. | MST |
| May 22, 2000 | K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LJM |
| May 22, 2000 | K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LJM |
| Feb 18, 2000 | K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | DDC |
| Feb 18, 2000 | K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | JZO |
| Nov 12, 1999 | K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. | MST |
| Sep 3, 1999 | K992166 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR Zeus Scientific, Inc. | LGC |
| Sep 3, 1999 | K991185 | BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM Zeus Scientific, Inc. | LSR |
| Sep 3, 1999 | K991180 | BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM Zeus Scientific, Inc. | LSR |
| Aug 12, 1999 | K991820 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI Zeus Scientific, Inc. | LYR |
| Jul 20, 1999 | K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LFX |
| Jun 25, 1999 | K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. | DDC |
| Jun 17, 1999 | K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | DDC |
| May 26, 1999 | K984135 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR Zeus Scientific, Inc. | GQL |
| May 26, 1999 | K984120 | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH Zeus Scientific, Inc. | GQL |
| May 26, 1999 | K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO Zeus Scientific, Inc. | LFX |
| Mar 26, 1999 | K990207 | GLIADIN IGA ELISA TEST SYSTEM Zeus Scientific, Inc. | MST |
| Mar 26, 1999 | K990204 | GLIADIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | MST |
| Mar 23, 1999 | K984138 | APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM Zeus Scientific, Inc. | LSR |
Newest 50 of 142.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | Zeus Scientific, Inc. ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G Open, Classified |
MYL | None listed |
| Dec 21, 2023 | Zeus Scientific, Inc. ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M Open, Classified |
MYL | None listed |
| Aug 12, 2019 | Zeus Scientific, Inc. ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of Terminated |
MYM | None listed |
| Jul 22, 2019 | Zeus Scientific, Inc. Dynex DSX Software-IVD ELISA Assays effected as follows:
DSX Assay File Software:
ZEUS vl B. burgdorferi lgG-lgM.asy
ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy
ZEUS Parvovirus B19 lgG (9Z7701G).asy
ZE Terminated |
N/A | None listed |
| May 8, 2012 | Zeus Scientific, Inc. AtheNA Multi-Lyte MMV Test System- A93111G
A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheN Terminated |
LJY | K961204 |
| Mar 31, 2009 | Zeus Scientific Inc Sm ELISA Test System
Product number 2Z2831G and Product number 43270CE
Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70.
Manufactured by Zeus Scien Terminated |
LJM | K941409 |
| Nov 20, 2004 | Zeus Scientific Inc Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, subst Terminated |
MID | K981021 |
| Aug 21, 2003 | Zeus Scientific Inc Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. Terminated |
MID | K984173 |
| Aug 12, 2003 | Zeus Scientific Inc Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ. Terminated |
LFZ | K891081 |
| Jul 30, 2003 | Zeus Scientific Inc Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigm Terminated |
LFX | K984180 |
| Jul 19, 2003 | Zeus Scientific Inc Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ. Terminated |
DHR | K961277 |
| Jul 2, 2003 | Zeus Scientific Inc Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is f Terminated |
LJB | None listed |