FDA applicant

Immunodiagnostics Systems Limited

Boldon, GB1 decision2026–20260 recalls

FDA records 1 decision for Immunodiagnostics Systems Limited (Boldon, GB) in 2026: 1 510(k) clearance. All are in product code LLL (Extractable Antinuclear Antibody, Antigen And…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Immunodiagnostics Systems Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Immunodiagnostics Systems Limited by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Immunodiagnostics”

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

Immunodiagnostics, Ltd. 1

Immunodiagnostics Systems Limited

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Immunodiagnostics”