FDA applicant

Digene Diagnostics, Inc.

Silver Spring, MD1 decision1995–19950 recalls

FDA records 1 decision for Digene Diagnostics, Inc. (Silver Spring, MD) in 1995: 1 510(k) clearance. All are in product code JJQ (Colorimeter, Photometer, Spectrophotometer For…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Digene Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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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 Corp. 9

Digene Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Digene”