Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Qiagen and its 5 subsidiaries with 39 device recalls and 29 510(k) clearances. The most recent is a 510(k) clearance dated Sep 24, 2026: QIAstat-Dx BCID GN Plus AMR Panel.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 68, 6 entities
Device recalls: 39
510(k) clearances: 29
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Qiagen and its 5 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
520182018Records5vs 2017+4
42019Records4vs 2018−1
420202020Records4vs 2019+0
32021Records3vs 2020−1
1020222022Records10vs 2021+7
82023Records8vs 2022−2
620242024Records6vs 2023−2
52025Records5vs 2024−1
320262026 to dateRecords3
Latest Records
Newest first across sources; each opens the record
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
