Axis-Shield Diagnostics, Ltd.
Medical device manufacturer in Dundee, GB.
28510(k) clearances
0PMA approvals
5recalls
Device types
- NHX Antibodies, Anti-Cyclic Citrullinated… 6
- CDD Radioassay, Vitamin B12 6
- JZO System, Test, Thyroid Autoantibody 3
- NBC Test, Natriuretic Peptide 3
- LPS Urinary Homocystine (Nonquantitative) Test… 3
- LCP Assay, Glycosylated Hemoglobin 2
- MID System, Test, Anticardiolipin Immunological 1
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 1
- CDZ Radioimmunoassay, Testosterones And… 1
- JKR Radioimmunoassay, Calcitonin 1
- GGT Assay, Erythropoietin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | 01/16/2025SE |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | 07/31/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | 08/02/2019SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | 12/21/2018SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | 10/27/2017SE |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | 07/26/2016SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | 03/22/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | 12/12/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | 05/07/2012SE |
| K112443 | Architect Active B-12 (Holotranscobalamin)CDD · Traditional | 12/19/2011SE |
| K110296 | Axis-Shield Anti-CcpNHX · Traditional | 08/18/2011SE |
| K083868 | Architect Anti-Ccp (100 Test), Architect Anti-Ccp (500 Test), Models 1P65-25, 1P65-35NHX · Traditional | 09/25/2009SE |
| K083222 | Axis-Shield Liquid Stable (LS) 2-PART Homocysteine Reagent, Model FHRK100LPS · Traditional | 07/31/2009SE |
| K073640 | Architect Homocysteine Reagents, Calibrators and ControlsLPS · Traditional | 04/24/2008SE |
| K072686 | Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsLCP · Traditional | 03/17/2008SE |
| K063347 | Axsym Anti-Ccp Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01…NHX · Traditional | 03/20/2007SE |
| K062467 | Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01…CDD · Traditional | 11/22/2006SE |
| K041866 | Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)CDZ · Traditional | 09/29/2004SE |
| K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) TestNBC · Traditional | 01/30/2004SE |
| K031177 | Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100MMSV · Traditional | 06/19/2003SE |
| K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-Ccp) ElisaNHX · Traditional | 10/09/2002SE |
| K021516 | Diastat Anti Cyclic Citrullinated Peptide Elisa, Model FCCP 200NHX · Traditional | 07/23/2002SE |
| K020687 | Diastat Anti-Thyroid Peroxidase Elisa Model #300JZO · Traditional | 05/02/2002SE |
| K020349 | Abbott Axsym Anti-Thyroglobulin, Models 5F5B Comprising Standard/CalibratorsJZO · Traditional | 05/02/2002SE |
| K020348 | Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/CalibratorsJZO · Traditional | 05/02/2002SE |
| K020156 | Diastat Total Anti-Cardiolipin, Model Fcar 100TMID · Traditional | 03/06/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0744-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | 09/16/2019Open, Classified |
| Z-0743-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | 09/16/2019Open, Classified |
| Z-0742-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | 09/16/2019Open, Classified |
| Z-1946-2015 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test…Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under… | 03/20/2015Terminated |
| Z-0003-2007 | Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong… | 11/11/2005Terminated |