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 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biogenex Laboratories with 12 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 1, 2014: InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use..
| Jul 1, 2014 | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.Class II · Product was distributed without 510(k) approval. | Device recalls |
| Mar 8, 2002 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK012960 · MXZ | 510(k) clearances |
| Feb 28, 2002 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K013148 · MYA | 510(k) clearances |
| Jan 6, 1993 | PREGNAGEN 1-STEP PREGNANCY TESTK925189 · LCX | 510(k) clearances |
| Jul 17, 1990 | MODIFIED OVUGENK902208 · CEP | 510(k) clearances |
| Jan 13, 1989 | PREGNAGEN(TM)K884880 · JHI | 510(k) clearances |
| Sep 9, 1988 | PREGNAGEN(TM)K882002 · JHI | 510(k) clearances |
| Nov 23, 1987 | OVUGEN SURETESTK873534 · CEP | 510(k) clearances |
| Jun 2, 1983 | RIAGEN B-HCG RIA KITK831221 · JHI | 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
