Axis-Shield

Device name

Alere NT-proBNP for Alinity Reagents

Model / reference

04S7930

Primary DI / UDI-DI

05055845400466

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 (eCLIA) 0320511103 by Shenzhen Lifotronic Technology Co., Ltd.
• N-terminal pro-B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit 100tests/kit by Nanjing RealMind Biotech Co., Ltd.
• BNP STAT (eCLIA) 0320509701 by Shenzhen Lifotronic Technology Co., Ltd.
• NT-proBNP STAT (EECL) 1042201000 by Accucise Diagnostics Inc.
• Beta amyloid protein 1-40 (Aβ1-40) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA) by JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
• N-terminal pro–B-type Natriuretic Peptide Test Kit (CLIA) CDBNP-401a by Healgen Life Science LLC
• BNP Fast Test Kit (Immunofluorescence Assay) IF3089 by Getein Biotech, Inc
• Access NT-proBNP (Reagent Pack) C71977 by IMMUNOTECH SAS
• Access BNP (Reagent Pack) 98200 by Beckman Coulter, Inc.
• NT-proBNP Fast Test Kit (Immunofluorescence Assay) IF5002 by Getein Biotech, Inc

• 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 →