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.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Orgentec Diagnostika and its 1 subsidiaries with 13 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 2010: ORGENTEC RHEUMATOID FACTOR EIA.
| Date | Record | Source |
|---|---|---|
| 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 |
| May 8, 1996 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYK954830 · LKP | 510(k) clearances |
| May 8, 1996 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYK954831 · LKO | 510(k) clearances |
| Apr 18, 1996 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYK954815 · LJM | 510(k) clearances |
| Apr 18, 1996 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYK954829 · LJM | 510(k) clearances |
| Apr 18, 1996 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYK954832 · 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
