FDA applicant

Qiagen Gaithersburg, Inc.

Germantown1 decision1991–19910 recalls

FDA records 1 decision for Qiagen Gaithersburg, Inc. (Germantown) in 1991: 1 original PMA approval. All are in product code MAQ (Kit, Dna Detection, Human Papillomavirus). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Qiagen Gaithersburg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qiagen Gaithersburg, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qiagen Gaithersburg, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qiagen Gaithersburg, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Qiagen”

FDA records each applicant name separately; these may or may not be the same firm.

QIAGEN GmbH 29 QIAGEN Manchester, Ltd. 1

Qiagen Gaithersburg, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Qiagen”