Atlas FDA

Axis-Shield Diagnostics, Ltd.

24 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Alere NT-proBNP for Alinity i (K253539)Axis-Shield Diagnostics, Ltd.2026-02-18
Alere NT-proBNP for Alinity i Reagent Kit (K241176)Axis-Shield Diagnostics, Ltd.2025-01-16
ARCHITECT Active-B12 (Holotranscobalamin) (K233541)Axis-Shield Diagnostics, Ltd.2024-07-31
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (K172133)Axis-Shield Diagnostics, Ltd.2017-10-27
AXIS-SHIELD ACVTIVE-B12 (K121946)Axis-Shield Diagnostics, Ltd.2013-03-22
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (K121842)Axis-Shield Diagnostics, Ltd.2012-12-12
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790)Axis-Shield Diagnostics, Ltd.2012-05-07
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (K112443)Axis-Shield Diagnostics, Ltd.2011-12-19
AXIS-SHIELD ANTI-CCP (K110296)Axis-Shield Diagnostics, Ltd.2011-08-18
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 (K083868)Axis-Shield Diagnostics, Ltd.2009-09-25
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (K083222)Axis-Shield Diagnostics, Ltd.2009-07-31
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (K073640)Axis-Shield Diagnostics, Ltd.2008-04-24
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS (K072686)Axis-Shield Diagnostics, Ltd.2008-03-17
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 (K063347)Axis-Shield Diagnostics, Ltd.2007-03-20
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 (K062467)Axis-Shield Diagnostics, Ltd.2006-11-22
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) (K041866)Axis-Shield Diagnostics, Ltd.2004-09-29
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST (K033606)Axis-Shield Diagnostics, Ltd.2004-01-30
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M (K031177)Axis-Shield Diagnostics, Ltd.2003-06-19
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA (K023285)Axis-Shield Diagnostics, Ltd.2002-10-09
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 (K021516)Axis-Shield Diagnostics, Ltd.2002-07-23
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 (K020687)Axis-Shield Diagnostics, Ltd.2002-05-02
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS (K020349)Axis-Shield Diagnostics, Ltd.2002-05-02
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS (K020348)Axis-Shield Diagnostics, Ltd.2002-05-02
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T (K020156)Axis-Shield Diagnostics, Ltd.2002-03-06

Track Axis-Shield Diagnostics, Ltd. automatically

Every clearance here is in the API, with alerts when new ones post.