Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NorwayLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AbbottLabelled 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 Axis-Shield POC with 4 510(k) clearances. The most recent is a 510(k) clearance dated Mar 21, 2014: AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL.
| Date | Record | Source |
|---|---|---|
| Mar 21, 2014 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLK132031 · CHH | 510(k) clearances |
| Feb 15, 2011 | AFINION ANALYZERK110056 · LCP | 510(k) clearances |
| Feb 12, 2008 | AFINION ACR AND ACR CONTROLK072409 · JFY | 510(k) clearances |
| Jul 22, 2005 | AFINION HBALCK050574 · LCP | 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
