Axis-Shield

Device name

Alere NT-proBNP for ARCHITECT Control Kit

Model / reference

2R10-11

Primary DI / UDI-DI

05055845400503

Basic UDI-DI

50558454NTP0009MK

EMDN code

W0102152004 Cardiac marker controls

Device class

Class C

EU registration type

Standard device

EU market of registration

Ireland

EUDAMED SRN

GB-MF-000001886

Authorised representative

Abbott Rapid Dx International Limited IE-AR-000000091

Other devices filed under CARDIAC MARKER CONTROLS.

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• Myo Control (CLIA) QC501 by Getein Biotech, Inc
• Cardiac Combo (cTnI/CK-MB) Control Solution (FIA) VIC45-03-011 by Vivachek Biotech (Hangzhou) Co., Ltd.
• MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-202 by Microgenics Corporation
• ABX PENTRA LOW CRP CONTROL 1220001731 by Horiba Abx
• cTnI Control (CLIA) QC507 by Getein Biotech, Inc
• VALIDATE® CM1 Test Set 401ab by LGC Clinical Diagnostics, Inc.
• Multi Control Cardiac Marker 691028 by Shenzhen Lifotronic Technology Co., Ltd.
• RAMP® Cardiac Controls - Level 2 C5003-2 by Response Biomedical Corp

• Axis-Shield

  Class C

  CE/IVDR

• Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR100 Open recall

  Class II

  CE/IVDR FDA 510(k) K083222 Active Cleared 31 Jul 2009 +1authorizations

• Alere NT-proBNP for Alinity Control Kit 04S7911

  Class I

  CE/IVDR GUDID on market

• Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR200 Open recall

  Not classified

  CE/IVDR FDA 510(k) K083222 Active Cleared 31 Jul 2009 +1authorizations

See all devices from Axis-Shield Diagnostics Limited →