Product code NBC
- Device name
- Test, Natriuretic Peptide
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1117
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252169 | Access BNP II | Beckman Coulter, Inc. | 2026-03-24 |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | 2026-02-18 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | 2025-01-16 |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024-04-12 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2023-07-21 |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2022-03-31 |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021-11-08 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics | 2021-10-04 |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | 2020-08-24 |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | Roche Diagnostics Corp. | 2010-02-04 |
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | Siemens Healthcare Diagnostics | 2008-09-22 |
| K063662 | RAMP NT-PROBNP ASSAY | Response Biomedical Corp. | 2008-07-21 |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Biosite Incorporated | 2008-06-06 |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | 2008-05-16 |
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | bioMerieux, Inc. | 2008-02-29 |
| K072437 | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | Roche Diagnostics | 2008-02-05 |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | Mitsubishi Kagaku Iatron | 2008-02-05 |
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | Dade Behring, Inc. | 2007-08-17 |
| K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | Dade Behring, Inc. | 2007-08-04 |
| K061795 | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-09-11 |
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | I-Stat Corporation | 2006-07-21 |
| K060632 | VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 | Ortho-Clinical Diagnostics, Inc. | 2006-06-06 |
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 | Fujirebio Diagnostics,Inc. | 2006-05-25 |
| K051596 | STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 | Nanogen, Inc. | 2006-03-13 |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Biosite Incorporated | 2006-01-23 |
| K051382 | ELECSYS PROBNP IMMUNOASSAY | Roche Diagnostics Corp. | 2005-12-05 |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | Biosite Incorporated | 2005-09-22 |
| K051265 | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Bayer Healthcare, LLC | 2005-06-13 |
| K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | Bayer Healthcare, LLC | 2005-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590786533 | Access BNP II | Beckman Coulter, Inc. | 2026-03-30 |
| 05055845400596 | Alere NT-proBNP for Alinity Reagent Kit (200 Tests) | AXIS-SHIELD DIAGNOSTICS LIMITED | 2025-02-26 |
| 15099590760823 | Access NT-proBNP | Beckman Coulter, Inc. | 2024-04-19 |
| 07613336217689 | Elecsys ProBNP II | Roche Diagnostics GmbH | 2024-02-19 |
| 00630414284958 | Atellica IM PBNPII | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414284941 | Atellica IM PBNPII | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414284934 | ADVIA Centaur PBNPII | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414284927 | ADVIA Centaur PBNPII | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 14560189212876 | ST AIA-PACK BNP | TOSOH CORPORATION | 2021-01-01 |
| 00630414293462 | Atellica IM BNP | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 30014613337959 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337966 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 04015630939756 | Elecsys proBNP II | Roche Diagnostics GmbH | 2017-04-21 |
| 00895160002458 | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION | 2016-10-03 |
| 00899722002177 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00893038002814 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00893038002807 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00893038002364 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00893038002289 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00842768004407 | Stratus® CS Acute Care™ ßhCG TestPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004667 | Stratus® CS Acute Care™ pBNP DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768019722 | Stratus® CS Acute Care™ pBNP CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630939190 | Elecsys Pro BNP II Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630939206 | Elecsys proBNP II STAT Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 10627966005046 | RAMP® NT-proBNP TEST KIT; 25 TESTS | Response Biomedical Corp | 2016-09-15 |
| 10054749000217 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |
| 03573026231453 | VIDAS® NT-proBNP | BIOMERIEUX SA | 2016-08-31 |
| 00380740017477 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740017460 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 10758750002061 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2015-12-22 |