Zeus Scientific, Inc.
FDA Regulatory Profile
Zeus Scientific, Inc. appears in FDA public data with 4 recalls, 141 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0603-2024, Class II) was initiated on October 31, 2023. Its most recent 510(k) clearance was granted on May 8, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 141
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0603-2024 | Class II | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G | October 31, 2023 |
| Z-0602-2024 | Class II | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M | October 31, 2023 |
| Z-3026-2020 | Class II | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qual | August 12, 2019 |
| Z-2494-2019 | Class II | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burg | July 22, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | May 8, 2026 |
| K250666 | Alegria Flash CTD Screen | October 22, 2025 |
| K250408 | Alegria Flash ENA Screen | September 19, 2025 |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Form | May 7, 2025 |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | August 31, 2023 |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM C | July 13, 2023 |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | April 29, 2022 |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test Syste | July 29, 2019 |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test S | July 29, 2019 |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test Syste | July 29, 2019 |
| K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | July 26, 2012 |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | December 12, 2011 |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | May 20, 2011 |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | April 26, 2011 |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | February 10, 2011 |
| K093784 | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM | July 16, 2010 |
| K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | July 6, 2010 |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | May 30, 2008 |
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | December 6, 2007 |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | July 5, 2007 |