FDA applicant
Axis-Shield Diagnostics, Ltd.
FDA records 28 decisions for Axis-Shield Diagnostics, Ltd. (Dundee, GB) from 2002 to 2026: 28 510(k) clearances. Most are in product codes NHX (Antibodies, Anti-Cyclic Citrullinated Peptide…) and CDD (Radioassay, Vitamin B12). Its devices cite 20 predicates, 10 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Axis-Shield Diagnostics Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Axis-Shield Diagnostics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Axis-Shield Diagnostics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Axis-Shield”
FDA records each applicant name separately; these may or may not be the same firm.