FDA applicant

Shield Diagnostics, Ltd.

Dundee, GB27 decisions1990–200010 recalls

FDA records 27 decisions for Shield Diagnostics, Ltd. (Dundee, GB) from 1990 to 2000: 27 510(k) clearances. Most are in product codes MID (System, Test, Anticardiolipin Immunological) and GGP (Test, Qualitative And Quantitative Factor…). 10 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, immunology panel, where it files most

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

FDA decisions per year

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

Recalls per year

2in 2017

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Shield 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 “Shield”

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

Shield Gloves Manufacturer (M) Sdn Bhd 18 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. 5 Shield Laboratories, Inc. 2 Shield Gloves Medical Products Sdn Bhd 1 Shield Computers, Ltd. 1

Shield Diagnostics, Ltd.

Which product codes does it file in?

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 “Shield”