Axis-Shield Diagnostics, Ltd. - FDA 510(k) Cleared Devices

Cleared Feb 18, 2026

Alere NT-proBNP for Alinity i

K253539 · NBC

Chemistry · 97d

Cleared Jan 16, 2025

Alere NT-proBNP for Alinity i Reagent Kit

K241176 · NBC

Chemistry · 262d

Cleared Jul 31, 2024

ARCHITECT Active-B12 (Holotranscobalamin)

K233541 · CDD

Chemistry · 271d

Cleared Oct 27, 2017

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

K172133 · CDD

Chemistry · 105d

Cleared Mar 22, 2013

AXIS-SHIELD ACVTIVE-B12

K121946 · CDD

Chemistry · 262d

Cleared Dec 12, 2012

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

K121842 · LCP

Chemistry · 170d

Cleared May 07, 2012

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

K112790 · LPS

Chemistry · 224d

Cleared Dec 19, 2011

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

K112443 · CDD

Chemistry · 117d

Cleared Jul 31, 2009

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

K083222 · LPS

Chemistry · 270d

Cleared Apr 24, 2008

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

K073640 · LPS

Chemistry · 120d

Cleared Mar 17, 2008

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

K072686 · LCP

Chemistry · 175d

Cleared Nov 22, 2006

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20

K062467 · CDD

Chemistry · 90d