Company ยท GB
Axis-Shield Diagnostics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | 7 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 7 |
| CDD | Radioassay, Vitamin B12 | 6 |
| JZO | System, Test, Thyroid Autoantibody | 3 |
| NBC | Test, Natriuretic Peptide | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| GGT | Assay, Erythropoietin | 1 |
| JKR | Radioimmunoassay, Calcitonin | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 2026 | K253539 | Alere NT-proBNP for Alinity i Axis-Shield Diagnostics, Ltd., GB | NBC |
| Jan 16, 2025 | K241176 | Alere NT-proBNP for Alinity i Reagent Kit Axis-Shield Diagnostics, Ltd., GB | NBC |
| Jul 31, 2024 | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) Axis-Shield Diagnostics, Ltd., GB | CDD |
| Aug 2, 2019 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay Axis-Shield Diagnostics Limited, GB | GGT |
| Dec 21, 2018 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay Axis-Shield Diagnostics Limited, GB | JKR |
| Oct 27, 2017 | K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay Axis-Shield Diagnostics, Ltd., GB | CDD |
| Aug 4, 2016 | K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. Axis-Shield Diagnostics Limited, GB | NHX |
| Jul 26, 2016 | K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Cen Axis-Shield Diagnostics Limited, GB | CDD |
| Mar 22, 2013 | K121946 | AXIS-SHIELD ACVTIVE-B12 Axis-Shield Diagnostics, Ltd., GB | CDD |
| Dec 12, 2012 | K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C Axis-Shield Diagnostics, Ltd., GB | LCP |
| May 7, 2012 | K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON Axis-Shield Diagnostics, Ltd., GB | LPS |
| Dec 19, 2011 | K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) Axis-Shield Diagnostics, Ltd., GB | CDD |
| Aug 18, 2011 | K110296 | AXIS-SHIELD ANTI-CCP Axis-Shield Diagnostics, Ltd., GB | NHX |
| Sep 25, 2009 | K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 Axis-Shield Diagnostics, Ltd., GB | NHX |
| Jul 31, 2009 | K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd., GB | LPS |
| Apr 24, 2008 | K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS Axis-Shield Diagnostics, Ltd., GB | LPS |
| Mar 17, 2008 | K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS Axis-Shield Diagnostics, Ltd., GB | LCP |
| Mar 20, 2007 | K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 Axis-Shield Diagnostics, Ltd., GB | NHX |
| Nov 22, 2006 | K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 Axis-Shield Diagnostics, Ltd., GB | CDD |
| Sep 29, 2004 | K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) Axis-Shield Diagnostics, Ltd., GB | CDZ |
| Jan 30, 2004 | K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST Axis-Shield Diagnostics, Ltd., GB | NBC |
| Jun 19, 2003 | K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M Axis-Shield Diagnostics, Ltd., GB | MSV |
| Oct 9, 2002 | K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA Axis-Shield Diagnostics, Ltd., GB | NHX |
| Jul 23, 2002 | K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 Axis-Shield Diagnostics, Ltd., GB | NHX |
| May 2, 2002 | K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 Axis-Shield Diagnostics, Ltd., GB | JZO |
| May 2, 2002 | K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS Axis-Shield Diagnostics, Ltd., GB | JZO |
| May 2, 2002 | K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS Axis-Shield Diagnostics, Ltd., GB | JZO |
| Mar 6, 2002 | K020156 | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T Axis-Shield Diagnostics, Ltd., GB | MID |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. 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 hyperhomocystein Open, Classified |
LPS | K083222 |
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. 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 hyperhomocysteine Open, Classified |
LPS | K083222 |
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. 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 hyperhomocysteinem Open, Classified |
LPS | K083222 |
| Jul 1, 2015 | Axis-Shield Diagnostics, Ltd. 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 th Terminated |
LPS | K083222 |
| Oct 3, 2006 | Axis-Shield Diagnostics, Ltd. Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) Terminated |
NHX | K021516 K023285 |