FDA applicant

Digene Corp.

Beltsville, MD9 decisions1997–20012 recalls

FDA records 9 decisions for Digene Corp. (Beltsville, MD) from 1997 to 2001: 9 510(k) clearances. Most are in product codes LSK (Dna-Reagents, Chlamydia) and LSL (Dna-Reagents, Neisseria). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are 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 Digene Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digene Corp. since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Digene”

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

Digene Diagnostics, Inc. 1

Digene Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Digene”