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 13, 2026, FDA's public records list Intracel with 5 510(k) clearances. The most recent is a 510(k) clearance dated Nov 7, 2000: BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT.
| Nov 7, 2000 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITK003204 · GNW | 510(k) clearances |
| Dec 21, 1999 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTK991074 · MJH | 510(k) clearances |
| Mar 31, 1999 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEWK990664 · LLH | 510(k) clearances |
| Dec 14, 1998 | BARTELS CINAKIT CMV ANTIGENEMIAK982311 · GQH | 510(k) clearances |
| Nov 14, 1995 | ZYMMUNE(TM) CD4/CD8 CELL MONITORING KITK933878 · 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
