Medical Device Manufacturer · GB , Dundee

Axis-Shield Diagnostics Limited

4 submissions · 4 cleared · Since 2016

Total

Cleared

Denied

Axis-Shield Diagnostics Limited — FDA 510(k) Submissions

Axis-Shield Diagnostics Limited has submitted 4 FDA 510(k) premarket notifications since 2016, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Erythropoietin, Antibodies, Anti-cyclic Citrullinated Peptide (ccp), Radioassay, Vitamin B12, Radioimmunoassay, Calcitonin . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

ADVIA Centaur Erythropoietin (EPO) assay

K183088 · GGT Assay, Erythropoietin · Hematology

Aug 2019 269d

ADVIA Centaur Calcitonin (CALCT) assay

K182012 · JKR Radioimmunoassay, Calcitonin · Chemistry

Dec 2018 147d

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

K153551 · NHX Antibodies, Anti-cyclic... · Immunology

Aug 2016 237d

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

K160757 · CDD Radioassay, Vitamin B12 · Chemistry

Jul 2016 130d

Axis-Shield Diagnostics Limited

Axis-Shield Diagnostics Limited — FDA 510(k) Submissions

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