Axis-Shield Diagnostics, Ltd.
FDA 510(k) medical device clearances.
Top product codes for Axis-Shield Diagnostics, Ltd.
Recent clearances by Axis-Shield Diagnostics, Ltd.
- K253539 — Alere NT-proBNP for Alinity i
- K241176 — Alere NT-proBNP for Alinity i Reagent Kit
- K233541 — ARCHITECT Active-B12 (Holotranscobalamin)
- K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
- K121946 — AXIS-SHIELD ACVTIVE-B12
- K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
- K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
- K110296 — AXIS-SHIELD ANTI-CCP
- K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
- K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
- K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
- K072686 — AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
- K063347 — AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
- K062467 — AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
- K041866 — ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
- K033606 — ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
- K031177 — DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
- K023285 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
- K021516 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
- K020348 — ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
- K020349 — ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
- K020687 — DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
- K020156 — DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
Data sourced from openFDA. This site is unofficial and independent of the FDA.