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 15, 2026, FDA's public records list Scantibodies Laboratory with 19 510(k) clearances. The most recent is a 510(k) clearance dated Aug 30, 2006: CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION).
| Aug 30, 2006 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)K060578 · JKR | 510(k) clearances |
| Mar 1, 2006 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002K060420 · CEW | 510(k) clearances |
| Feb 27, 2006 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITK060348 · CEW | 510(k) clearances |
| Oct 18, 2005 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013K051888 · CEW | 510(k) clearances |
| Sep 9, 2005 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014K051810 · CEW | 510(k) clearances |
| Jul 26, 2005 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITK051150 · CEW | 510(k) clearances |
| Jul 26, 2005 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002K051141 · CEW | 510(k) clearances |
| May 20, 2005 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011K050748 · CKG | 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
