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.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Enzo Biochem, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 3, 1988: COLORGENE HSV DNA HYBRIDIZATION TEST.
| Aug 3, 1988 | COLORGENE HSV DNA HYBRIDIZATION TESTK880604 · GQN | 510(k) clearances |
| Jul 8, 1988 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOODK881907 · KHE | 510(k) clearances |
| Mar 28, 1988 | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVK875367 · GQM | 510(k) clearances |
| Dec 4, 1987 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATIONK872576 · GQH | 510(k) clearances |
| May 26, 1987 | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.K870733 · GQN | 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
