FDA applicant

Genesis Diagnostics, Ltd.

Littleport, Cambridgeshire, GB1 decision1999–19990 recalls

FDA records 1 decision for Genesis Diagnostics, Ltd. (Littleport, Cambridgeshire, GB) in 1999: 1 510(k) clearance. All are in product code MST (Antibodies, Gliadin). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Genesis Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Genesis”

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

Genesis Industries, Inc. 17 Genesis Fracture Care, Inc. 5 Genesis Biosystems, Inc. 4 Genesis Labs, Inc. 3 Genesis Orthopedics, Inc. 2 Genesis Digital Imaging, Inc. 2 Genesis Software Innovations 2 Genesis Medical, Inc. 2 Genesis Medical Interventional, Inc. 2 Genesis Medical Technology, Inc. 1 Genesis Health Technologies 1 Genesis Air, Inc. 1

Genesis Diagnostics, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Genesis”