Axis-Shield Diagnostics, Ltd.
DUNDEE Scotland, GB
AXIS-SHIELD DIAGNOSTICS, LTD. appears in FDA device records in DUNDEE Scotland, GB. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Axis-Shield Diagnostics, Ltd. between 2002 and 2026. The busiest year on record is 2002, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 6 |
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253539 | Alere NT-proBNP for Alinity i | NBC | Substantially Equivalent | |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | NBC | Substantially Equivalent | |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | CDD | Substantially Equivalent | |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | GGT | Substantially Equivalent | |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | JKR | Substantially Equivalent | |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | CDD | Substantially Equivalent | |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | NHX | Substantially Equivalent | |
| 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) | CDD | Substantially Equivalent | |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | CDD | Substantially Equivalent | |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | LCP | Substantially Equivalent | |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | LPS | Substantially Equivalent | |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | CDD | Substantially Equivalent | |
| K110296 | AXIS-SHIELD ANTI-CCP | NHX | Substantially Equivalent | |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | NHX | Substantially Equivalent | |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | LPS | Substantially Equivalent | |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | LPS | Substantially Equivalent | |
| K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS | LCP | Substantially Equivalent | |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | NHX | Substantially Equivalent | |
| K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 | CDD | Substantially Equivalent | |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) | CDZ | Substantially Equivalent | |
| K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST | NBC | Substantially Equivalent | |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | MSV | Substantially Equivalent | |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | NHX | Substantially Equivalent | |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | NHX | Substantially Equivalent | |
| K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | JZO | Substantially Equivalent | |
| K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS | JZO | Substantially Equivalent | |
| K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS | JZO | Substantially Equivalent | |
| K020156 | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T | MID | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8032314 | 3002808140 | AXIS-SHIELD DIAGNOSTICS, LTD. | LUNA PLACE, DUNDEE Scotland DD2 1XA GB | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- GMQAntigens, Nontreponemal, All
- GGTAssay, Erythropoietin
- LCPAssay, Glycosylated Hemoglobin
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- QLCInterleukin 6
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CDDRadioassay, Vitamin B12
- JKRRadioimmunoassay, Calcitonin
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- MIDSystem, Test, Anticardiolipin Immunological
- JZOSystem, Test, Thyroid Autoantibody
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- NBCTest, Natriuretic Peptide
- LPSUrinary Homocystine (Nonquantitative) Test System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0744-2020 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | Class II | Open, Classified | |
| Z-0743-2020 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | Class II | Open, Classified | |
| Z-0742-2020 | 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 homocystinuria. The device is intended for Professional use only. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | Class II | Open, Classified | |
| Z-1946-2015 | 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 platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum. | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. | Class II | Terminated | |
| 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 concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain