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., part of Johnson & JohnsonLabelled 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. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Ortho Diagnostic Systems, Inc. with 126 510(k) clearances. The most recent is a 510(k) clearance dated Jul 14, 1997: ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE.
| Jul 14, 1997 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951459 · GKZ | 510(k) clearances |
| Mar 6, 1997 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K951632 · GKZ | 510(k) clearances |
| Jan 22, 1997 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK964754 · GKZ | 510(k) clearances |
| Nov 29, 1996 | QUANTITATIVE FIBRINOGEN ASSAYK963902 · GIS | 510(k) clearances |
| May 13, 1996 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)K951100 · GKZ | 510(k) clearances |
| May 13, 1996 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K950568 · GKZ | 510(k) clearances |
| May 13, 1996 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950625 · GKZ | 510(k) clearances |
| May 10, 1996 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)K950482 · GKZ | 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
