Data / Medical devices / United Kingdom / Axis-Shield Diagnostics, Ltd.
Axis-Shield Diagnostics, Ltd.: FDA-registered device maker in DUNDEE Scotland, United Kingdom, 11 510(k) clearances
Axis-Shield Diagnostics, Ltd. is registered with the FDA (registration 8032314) in DUNDEE Scotland, United Kingdom. It lists 14 device types. The FDA files 11 510(k) clearances under its listings, the newest dated February 18, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8032314
- FEI number
- 3002808140
- Address
- Luna Place The Technology Park, DUNDEE Scotland, United Kingdom, DD2 1XA
- Owner or operator
- Abbott Laboratories (8032314)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 26, 2004
- Registered through
- 2027
- Brand names listed
- 3-Reagent Homocysteine Assay for SYNCHRON and UniCel, ABBOTT ARCHITECT 2nd Generation Testosterone, ABBOTT ARCHITECT Active-B12 (Holotranscobalamin), ABBOTT ARCHITECT Anti-CCP, ABBOTT ARCHITECT Homocysteine, ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay, ADVIA Centaur Erythropoietin (EPO) Assay (XP), ADVIA Centaur Lipopolysaccharide Binding Protein (LBP) Quality Control and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 18, 2026 | K253539 | Alere NT-proBNP for Alinity i | NBC | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| January 16, 2025 | K241176 | Alere NT-proBNP for Alinity i Reagent Kit | NBC | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| July 31, 2024 | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | CDD | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| March 22, 2013 | K121946 | AXIS-SHIELD ACVTIVE-B12 | CDD | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| May 7, 2012 | K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | LPS | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| December 19, 2011 | K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | CDD | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| August 18, 2011 | K110296 | AXIS-SHIELD ANTI-CCP | NHX | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| September 25, 2009 | K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | NHX | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| July 31, 2009 | K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | LPS | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| April 24, 2008 | K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | LPS | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| October 16, 1998 | K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | LPS | Substantially Equivalent | Axis Biochemicals, Asa | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2019 | 84043 | Class II | Ongoing | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuri | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | accessdata.fda.gov |
| March 20, 2015 | 70992 | Class II | Terminated | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. | accessdata.fda.gov |
| November 11, 2005 | 36018 | Not yet classified | Terminated | 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 concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%. | accessdata.fda.gov |
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Updated February 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.