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 Thermo Fisher ScientificLabelled by claude-haiku-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 14, 2026, FDA's public records list Affymetrix with 2 510(k) clearances and 1 device recall. The most recent is a device recall dated Apr 14, 2016: CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers….
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. TheClass III · During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the | Device recalls |
| Jan 17, 2014 | CYTOSCAN(R) DXDEN130018 · PFX | 510(k) clearances |
| May 4, 2011 | AFFYMETRIX GENE PROFILING REAGENTSK103112 · OVA | 510(k) clearances |
| Jul 30, 2008 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMK080995 · NSU | 510(k) clearances |
| Dec 23, 2004 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMDEN040012 · NSU | 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
