# Axis-Shield Diagnostics, Ltd.

- Location (FDA's records): Dundee, GB
- FDA decisions: 28 (2002–2026): 28 510(k) clearances
- Names in FDA's records: Axis-Shield Diagnostics, Ltd. (24); Axis-Shield Diagnostics Limited (4)
- Product codes: NHX (6), CDD (6), JZO (3), LPS (3), NBC (3), LCP (2), MSV (1), CDZ (1), MID (1), JKR (1), GGT (1)
- Predicates its devices cite: 20 (10 its own); citations of its devices by later devices: 15 (10 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Axis-Shield Biochemicals, Asa: 1 (https://510kreport.com/company/axis-shield-biochemicals)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Catch, Inc.: 1 (https://510kreport.com/company/catch)
- Biosite Incorporated: 1 (https://510kreport.com/company/biosite)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)
- Tosoh Medics, Inc.: 1 (https://510kreport.com/company/tosoh-medics)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Sweden Diagnostics (Us), Inc.: 1 (https://510kreport.com/company/sweden-diagnostics-us)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Fisher Diagnostics: 1 (https://510kreport.com/company/fisher-diagnostics)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa (2002), cited by 5
- K112443: Architect Active B-12 (Holotranscobalamin) (2011), cited by 3
- K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10 (2006), cited by 1
- K083868: Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models 1P65-25, 1P65-35 (2009), cited by 1
- K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 (2009), cited by 1
- K020348: Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/Calibrators (2002), cited by 1

## Recent decisions
- K253539: Alere NT-proBNP for Alinity i (Feb 18, 2026)
- K241176: Alere NT-proBNP for Alinity i Reagent Kit (Jan 16, 2025)
- K233541: ARCHITECT Active-B12 (Holotranscobalamin) (Jul 31, 2024)
- K183088: ADVIA Centaur Erythropoietin (EPO) assay (Aug 2, 2019)
- K182012: ADVIA Centaur Calcitonin (CALCT) assay (Dec 21, 2018)
- K172133: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (Oct 27, 2017)
- K153551: ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (Aug 4, 2016)
- K160757: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (Jul 26, 2016)

Source page: https://510kreport.com/company/axis-shield-diagnostics