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., part of WerfenLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Inova Diagnostics with 136 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Feb 6, 2026: Aptiva APS IgA Reagent.
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.
| Feb 6, 2026 | Aptiva APS IgA ReagentK243979 · MSV | 510(k) clearances |
| Dec 17, 2024 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK223093 · MID | 510(k) clearances |
| Sep 29, 2023 | Aptiva CTD Essential ReagentK213403 · LLL | 510(k) clearances |
| Aug 26, 2021 | Aptiva Celiac Disease IgG ReagentK200230 · MVM | 510(k) clearances |
| Jun 16, 2021 | Aptiva Celiac Disease IgA ReagentK193604 · MVM | 510(k) clearances |
| Dec 11, 2020 | NOVA Lite DAPI dsDNA Crithidia luciliae KitK192916 · KTL | 510(k) clearances |
| Apr 17, 2019 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsK190088 · DHR | 510(k) clearances |
| Oct 16, 2018 | QUANTA Flash Calprotectin and Fecal Extraction DeviceK180971 · NXO | 510(k) clearances |
| Jan 26, 2018 | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to aClass II · The device power supply was not manufactured according to specification which can result in the loss of the protective g | Device recalls |
| Jan 26, 2018 | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to aClass II · The device power supply was not manufactured according to specification which can result in the loss of the protective g | 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
