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 Disease Detection International with 20 510(k) clearances. The most recent is a 510(k) clearance dated Oct 25, 1994: PRO-STEP LH OVULATION PREDICTION TEST.
| Oct 25, 1994 | PRO-STEP LH OVULATION PREDICTION TESTK943252 · CEP | 510(k) clearances |
| Jun 15, 1993 | PRO-STEP PT HCGK925303 · JHI | 510(k) clearances |
| Jan 13, 1993 | PRO-STEP HCGK925125 · JHI | 510(k) clearances |
| Jul 19, 1991 | IMMUNOCARD HCG ONE STEP (I-S) TEST KITK911826 · JHI | 510(k) clearances |
| Sep 5, 1990 | MODIFICATION OF SEROCARD RUBELLA IGG TESTK902571 · LFX | 510(k) clearances |
| Aug 9, 1990 | SEROCARD HSV IGG ANTIBODY TEST KITK903070 · LGC | 510(k) clearances |
| Dec 1, 1989 | IMMUNOCARD HCG II-S TEST KITK895912 · JHI | 510(k) clearances |
| Nov 29, 1989 | IMMUNOCARD STREP A TESTK896109 · GTZ | 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
