Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Zeus Scientific with 143 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Aug 21, 2026: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 21, 2026 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMK261466 · MOB | 510(k) clearances |
| May 8, 2026 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBK250814 · OBE | 510(k) clearances |
| Oct 22, 2025 | Alegria Flash CTD ScreenK250666 · LLL | 510(k) clearances |
| Sep 19, 2025 | Alegria Flash ENA ScreenK250408 · LLL | 510(k) clearances |
| May 7, 2025 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)K243776 · MOB | 510(k) clearances |
| Oct 31, 2023 | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701GClass II · The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This mod | Device recalls |
| Oct 31, 2023 | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701MClass II · The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This mod | Device recalls |
| Aug 31, 2023 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineK231616 · KTL | 510(k) clearances |
| Jul 13, 2023 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitK230863 · LSR | 510(k) clearances |
| Apr 29, 2022 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineK201956 · DHN | 510(k) clearances |
| Aug 12, 2019 | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodieClass II · FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, th | Device recalls |
| Jul 22, 2019 | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlClass II · Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 bein | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
