Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Orgentec DiagnostikaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orgentec Diagnostika GmbH with 3 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 2010: ORGENTEC RHEUMATOID FACTOR EIA.
| Oct 27, 2010 | ORGENTEC RHEUMATOID FACTOR EIAK100499 · DHR | 510(k) clearances |
| Jul 1, 2010 | ANTI-MUTATED CITRULLINATED VIMENTIN EIAK092399 · OQZ | 510(k) clearances |
| May 2, 2003 | ANA DETECTK030929 · LJM | 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
