Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Immunodiagnostic Systems with 27 510(k) clearances. The most recent is a 510(k) clearance dated Apr 15, 2026: IDS-iSYS Total Testosterone.
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.
| Apr 15, 2026 | IDS-iSYS Total TestosteroneK252728 · CDZ | 510(k) clearances |
| Oct 23, 2024 | IDS-iSYS Free TestosteroneK240865 · CDZ | 510(k) clearances |
| Aug 18, 2023 | IDS ACTH IIK223867 · CKG | 510(k) clearances |
| Apr 13, 2021 | IDS CortisolK202136 · CGR | 510(k) clearances |
| Sep 30, 2020 | IDS-iSYS Ostase BAPK200475 · CIN | 510(k) clearances |
| Jun 17, 2019 | IDS SHBGK190121 · CDZ | 510(k) clearances |
| Jan 31, 2017 | IDS-iSYS Intact PTHNK161158 · CEW | 510(k) clearances |
| Nov 15, 2016 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetK161831 · MRG | 510(k) clearances |
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
