Medical Device Manufacturer · GB , Dundee

Axis-Shield Diagnostics, Ltd.

24 submissions · 24 cleared · Since 2002
24
Total
24
Cleared
0
Denied

Axis-Shield Diagnostics, Ltd. — FDA 510(k) Submissions

Axis-Shield Diagnostics, Ltd. has submitted 24 FDA 510(k) premarket notifications since 2002, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antibodies, Anti-cyclic Citrullinated Peptide (ccp), Radioassay, Vitamin B12, Urinary Homocystine (nonquantitative) Test System, System, Test, Thyroid Autoantibody, Test, Natriuretic Peptide . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
Alere NT-proBNP for Alinity i
K253539 · NBC Test, Natriuretic Peptide · Chemistry
Feb 2026 97d
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC Test, Natriuretic Peptide · Chemistry
Jan 2025 262d
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · CDD Radioassay, Vitamin B12 · Chemistry
Jul 2024 271d
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133 · CDD Radioassay, Vitamin B12 · Chemistry
Oct 2017 105d
AXIS-SHIELD ACVTIVE-B12
K121946 · CDD Radioassay, Vitamin B12 · Chemistry
Mar 2013 262d
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842 · LCP Assay, Glycosylated... · Chemistry
Dec 2012 170d
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
K112790 · LPS Urinary Homocystine... · Chemistry
May 2012 224d
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443 · CDD Radioassay, Vitamin B12 · Chemistry
Dec 2011 117d
AXIS-SHIELD ANTI-CCP
K110296 · NHX Antibodies, Anti-cyclic... · Immunology
Aug 2011 198d
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K083868 · NHX Antibodies, Anti-cyclic... · Immunology
Sep 2009 270d
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · LPS Urinary Homocystine... · Chemistry
Jul 2009 270d
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · LPS Urinary Homocystine... · Chemistry
Apr 2008 120d
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · LCP Assay, Glycosylated... · Chemistry
Mar 2008 175d
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
K063347 · NHX Antibodies, Anti-cyclic... · Immunology
Mar 2007 134d
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
K062467 · CDD Radioassay, Vitamin B12 · Chemistry
Nov 2006 90d
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866 · CDZ Radioimmunoassay,... · Chemistry
Sep 2004 82d
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
K033606 · NBC Test, Natriuretic Peptide · Chemistry
Jan 2004 74d
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · MSV System,test,antibodies,b2... · Immunology
Jun 2003 66d
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · NHX Antibodies, Anti-cyclic... · Immunology
Oct 2002 23d
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · NHX Antibodies, Anti-cyclic... · Immunology
Jul 2002 74d
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
K020348 · JZO System, Test, Thyroid... · Immunology
May 2002 87d
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · JZO System, Test, Thyroid... · Immunology
May 2002 87d
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · JZO System, Test, Thyroid... · Immunology
May 2002 59d
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156 · MID System, Test,... · Immunology
Mar 2002 48d
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