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 13, 2026, FDA's public records list IVD Research, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jan 14, 2009: GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF.
| Jan 14, 2009 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFK081064 · MHI | 510(k) clearances |
| May 27, 2004 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96K032897 · LLH | 510(k) clearances |
| Jul 10, 2003 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96K031059 · MHJ | 510(k) clearances |
| Mar 5, 2003 | IVD CRYPTO/GIARDIA DFAK024113 · MHI | 510(k) clearances |
| Sep 17, 2002 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96K020583 · MHI | 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
