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 14, 2026, FDA's public records list Affinity Biologicals with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 6, 2016: VisuCon-F Low Fibrinogen Control Plasma.
| Mar 6, 2016 | VisuCon-F Low Fibrinogen Control PlasmaK150144 · GGN | 510(k) clearances |
| Oct 20, 2011 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABNK110432 · GGN | 510(k) clearances |
| Oct 28, 2009 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMAK091284 · GGN | 510(k) clearances |
| Jan 20, 2006 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGK052825 · GGP | 510(k) clearances |
| Jun 29, 2005 | VISULIZE FACTOR IX ANTIGEN KITK051054 · GGP | 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
