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Axis-Shield Diagnostics, Ltd.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253539 Alere NT-proBNP for Alinity iNBC2026-02-18 View
510(k) K241176 Alere NT-proBNP for Alinity i Reagent KitNBC2025-01-16 View
510(k) K233541 ARCHITECT Active-B12 (Holotranscobalamin)CDD2024-07-31 View
510(k) K172133 ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD2017-10-27 View
510(k) K121946 AXIS-SHIELD ACVTIVE-B12CDD2013-03-22 View
510(k) K121842 ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CLCP2012-12-12 View
510(k) K112790 AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONLPS2012-05-07 View
510(k) K112443 ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)CDD2011-12-19 View
510(k) K110296 AXIS-SHIELD ANTI-CCPNHX2011-08-18 View
510(k) K083868 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35NHX2009-09-25 View
510(k) K083222 AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31 View
510(k) K073640 ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSLPS2008-04-24 View
510(k) K072686 AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLSLCP2008-03-17 View
510(k) K063347 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10NHX2007-03-20 View
510(k) K062467 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10CDD2006-11-22 View
510(k) K041866 ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)CDZ2004-09-29 View
510(k) K033606 ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TESTNBC2004-01-30 View
510(k) K031177 DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100MMSV2003-06-19 View
510(k) K023285 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISANHX2002-10-09 View
510(k) K021516 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200NHX2002-07-23 View
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