Diagnostics makerLabelled 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 Immuno-Diagnostic Products with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 24, 1986: EBV(EPSTEIN-BARR VIRUS) TEST KIT.
| Apr 24, 1986 | EBV(EPSTEIN-BARR VIRUS) TEST KITK854207 · GNP | 510(k) clearances |
| Nov 5, 1981 | HERPESK811021 · GQN | 510(k) clearances |
| Jul 16, 1981 | TOXOPLASMOSIS TEST KITK811562 · GLZ | 510(k) clearances |
| Apr 23, 1981 | ANA TEST KITK811022 · DHN | 510(k) clearances |
| Oct 23, 1980 | FTA-ABS TESTK801959 · JWL | 510(k) clearances |
| Oct 23, 1980 | CMV TEST KITK801963 · GQH | 510(k) clearances |
| Oct 10, 1980 | ANTI-DS/N-DNA TEST KITK801960 · DBL | 510(k) clearances |
| Oct 10, 1980 | RF-II TEST KITK801961 · DHR | 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
