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., part of Bio-TechneLabelled 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 Asuragen, Inc. with 1 510(k) clearance. The most recent is a 510(k) clearance dated Feb 21, 2020: AmplideX Fragile X Dx & Carrier Screen Kit.
| Feb 21, 2020 | AmplideX Fragile X Dx & Carrier Screen KitDEN190023 · OYV | 510(k) clearances |
| Jul 22, 2016 | Quantidex qPCR BCR-ABL IS KitDEN160003 · OYX | 510(k) clearances |
| Mar 16, 2012 | RNARETAINK113420 · OZF | 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
