Test, Natriuretic Peptide

FDA product code NBC · 45 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1117
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2001-03-16 – 2026-09-21

NBC 2026-09-21

Access NT-proBNP

Applicant Beckman Coulter, Inc.

K number K262109

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NBC 2026-03-24

Access BNP II

Applicant Beckman Coulter, Inc.

K number K252169

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NBC 2026-02-18

Alere NT-proBNP for Alinity i

Applicant Axis-Shield Diagnostics, Ltd.

K number K253539

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NBC 2025-01-16

Alere NT-proBNP for Alinity i Reagent Kit

Applicant Axis-Shield Diagnostics, Ltd.

K number K241176

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NBC 2024-04-12

Access NT-proBNP

Applicant Beckman Coulter, Inc.

K number K232164

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NBC 2023-09-24

ADVIA Centaur® NT-proBNPII (PBNPII)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K220265

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NBC 2023-07-21

Elecsys proBNP II, Elecsys proBNP II STAT

Applicant Roche Diagnostics

K number K223637

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NBC 2022-03-31

Elecsys proBNP II, Elecsys proBNP II STAT

Applicant Roche Diagnostics

K number K210546

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NBC 2021-11-08

ST AIA-PACK BNP Assay

Applicant Tosoh Bioscience, Inc.

K number K211199

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NBC 2021-10-04

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Applicant Ortho Clinical Diagnostics

K number K201312

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NBC 2020-08-24

ST AIA-PACK BNP

Applicant Fujirebio Diagnostics,Inc.

K number K192380

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NBC 2010-02-04

ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

Applicant Roche Diagnostics Corp.

K number K092649

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NBC 2008-09-22

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623

Applicant Siemens Healthcare Diagnostics

K number K082645

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NBC 2008-07-21

RAMP NT-PROBNP ASSAY

Applicant Response Biomedical Corp.

K number K063662

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NBC 2008-06-06

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

Applicant Biosite Incorporated

K number K080269

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NBC 2008-05-16

DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA

Applicant Siemens Healthcare Diagnostics, Inc.

K number K080578

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NBC 2008-02-29

VIDAS NT-PROBNP ASSAY, MODEL: 30 449

Applicant bioMerieux, Inc.

K number K073091

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NBC 2008-02-05

ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET

Applicant Roche Diagnostics

K number K072437

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NBC 2008-02-05

PATHFAST NTPROBNP AND D-DIMER TESTS

Applicant Mitsubishi Kagaku Iatron

K number K072189

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NBC 2007-08-17

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM

Applicant Dade Behring, Inc.

K number K071834

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NBC 2007-08-04

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

Applicant Dade Behring, Inc.

K number K071767

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NBC 2006-09-11

DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

Applicant Dade Behring, Inc.

K number K061795

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NBC 2006-07-21

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

Applicant I-Stat Corporation

K number K053597

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NBC 2006-06-06

VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

Applicant Ortho-Clinical Diagnostics, Inc.

K number K060632

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NBC 2006-05-25

ARCHITECT BNP ASSAY, MODEL 8K28

Applicant Fujirebio Diagnostics,Inc.

K number K060964

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NBC 2006-03-13

STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

Applicant Nanogen, Inc.

K number K051596

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NBC 2006-01-23

TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200

Applicant Biosite Incorporated

K number K052789

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NBC 2005-12-05

ELECSYS PROBNP IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K051382

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NBC 2005-09-22

TRIAGE BNP TEST, MODEL 98000XR

Applicant Biosite Incorporated

K number K051787

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NBC 2005-06-13

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

Applicant Bayer Healthcare, LLC

K number K051265

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NBC 2005-04-22

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

Applicant Bayer Healthcare, LLC

K number K043228

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NBC 2005-02-15

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

Applicant Dade Behring, Inc.

K number K043476

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NBC 2004-11-19

MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD

Applicant Dade Behring, Inc.

K number K042347

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NBC 2004-07-20

DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423

Applicant Dade Behring, Inc.

K number K041417

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NBC 2004-06-14

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

Applicant Bayer Healthcare, LLC

K number K040425

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NBC 2004-01-30

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

Applicant Axis-Shield Diagnostics, Ltd.

K number K033606

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NBC 2004-01-28

MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

Applicant Biosite Incorporated

K number K032235

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NBC 2003-12-23

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

Applicant Biosite Incorporated

K number K033383

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NBC 2003-11-12

ELECSYS PROBNP IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K032646

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NBC 2003-09-09

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

Applicant Bayer Healthcare, LLC

K number K032525

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NBC 2003-06-23

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

Applicant Bayer Healthcare, LLC

K number K031038

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NBC 2003-02-21

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

Applicant Biosite Incorporated

K number K030286

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NBC 2002-11-19

ELECSYS PROBNP IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K022516

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NBC 2002-07-01

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

Applicant Biosite Incorporated

K number K021317

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NBC 2001-03-16

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

Applicant Biosite Incorporated

K number K010266

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