Axis-Shield

Device name

Alere NT-proBNP for Alinity Reagents

Model / reference

04S7920

Primary DI / UDI-DI

05055845400435

Basic UDI-DI

50558454NTP0001M3

EMDN code

W01021301 Bnp / probnp (including other natriuric peptides)

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 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES).

• BNP CONTROLS FOR ABBOTT (BNP CONTROL) CQ10521 by RANDOX LABORATORIES LIMITED
• N-terminal pro-B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit 50tests/kit by Nanjing RealMind Biotech Co., Ltd.
• N-terminal pro B-type Natriuretic Peptide(Electrochemiluminescence Immunoassay) 691045 by Shenzhen Lifotronic Technology Co., Ltd.
• BNP Fast Test Kit (Immunofluorescence Assay) IF6089 by Getein Biotech, Inc
• BNP STAT (eCLIA) 0320509703 by Shenzhen Lifotronic Technology Co., Ltd.
• ADVIA Centaur PBNPII 11203760 by Siemens Healthcare Diagnostics Inc.
• ADVIA Centaur PBNPII 11203759 by Siemens Healthcare Diagnostics Inc.
• INNODX NBNP STAT CMIA KR-NBNP-03100 by Xiamen Innodx Biotech Co., Ltd.
• N-terminal pro-Brain Natriuretic Peptide Rapid Test Kit (QDs Immunofluorescence Method) 01W by Chongqing iSIA BIO-Technology Co., Ltd.
• Brain Natriuretic Peptide Test Kit (CLIA) CDBNA-301a by Healgen Life Science LLC

• 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 →