ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY— 510(k) K031038

Clearance details

Applicant

Bayer Healthcare, LLC

Product code

Code NBC

Device class

Class 2

Regulation

21 CFR 862.1117

Advisory panel

Clinical Chemistry

Date received

2003-04-01

Decision date

2003-06-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarrytown, NY, US

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• Z-2053-2018 — ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20171218
• Z-0229-2015 — ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)Class III·Terminated·Siemens Healthcare Diagnostics, Inc·20141006
• Z-2149-2014 — SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20140623
• Z-2150-2014 — SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20140623
• Z-0506-2013 — Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20121114
• Z-2313-2012 — Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20120725

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031038.