FDA Product Code
FDA Product Code NBC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1117
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262109 | Access NT-proBNP | Beckman Coulter, Inc. | 2026-09-21 | Traditional | PDF ↗ |
| K252169 | Access BNP II | Beckman Coulter, Inc. | 2026-03-24 | Traditional | PDF ↗ |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | 2026-02-18 | Traditional | PDF ↗ |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | 2025-01-16 | Traditional | PDF ↗ |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024-04-12 | Traditional | PDF ↗ |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 | Traditional | PDF ↗ |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2023-07-21 | Traditional | PDF ↗ |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2022-03-31 | Traditional | PDF ↗ |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021-11-08 | Special | PDF ↗ |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics | 2021-10-04 | Traditional | PDF ↗ |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | 2020-08-24 | Traditional | PDF ↗ |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | Roche Diagnostics Corp. | 2010-02-04 | Special | PDF ↗ |
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | Siemens Healthcare Diagnostics | 2008-09-22 | Special | PDF ↗ |
| K063662 | RAMP NT-PROBNP ASSAY | Response Biomedical Corp. | 2008-07-21 | Traditional | PDF ↗ |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Biosite Incorporated | 2008-06-06 | Traditional | PDF ↗ |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | 2008-05-16 | Traditional | PDF ↗ |
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | bioMerieux, Inc. | 2008-02-29 | Traditional | PDF ↗ |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | Mitsubishi Kagaku Iatron | 2008-02-05 | Traditional | PDF ↗ |
| K072437 | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | Roche Diagnostics | 2008-02-05 | Traditional | PDF ↗ |
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | Dade Behring, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | Dade Behring, Inc. | 2007-08-04 | Traditional | PDF ↗ |
| K061795 | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | I-Stat Corporation | 2006-07-21 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 | Fujirebio Diagnostics,Inc. | 2006-05-25 | Traditional | PDF ↗ |
| K051596 | STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 | Nanogen, Inc. | 2006-03-13 | Traditional | PDF ↗ |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Biosite Incorporated | 2006-01-23 | Traditional | PDF ↗ |
| K051382 | ELECSYS PROBNP IMMUNOASSAY | Roche Diagnostics Corp. | 2005-12-05 | Traditional | PDF ↗ |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | Biosite Incorporated | 2005-09-22 | Traditional | PDF ↗ |
| K051265 | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Bayer Healthcare, LLC | 2005-06-13 | Traditional | PDF ↗ |
| K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | Bayer Healthcare, LLC | 2005-04-22 | Traditional | PDF ↗ |
| K043476 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT | Dade Behring, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K042347 | MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD | Dade Behring, Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K041417 | DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 | Dade Behring, Inc. | 2004-07-20 | Traditional | PDF ↗ |
| K040425 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | Bayer Healthcare, LLC | 2004-06-14 | Traditional | PDF ↗ |
| K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST | Axis-Shield Diagnostics, Ltd. | 2004-01-30 | Traditional | PDF ↗ |
| K032235 | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Biosite Incorporated | 2004-01-28 | Traditional | PDF ↗ |
| K033383 | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 | Biosite Incorporated | 2003-12-23 | Traditional | PDF ↗ |
| K032646 | ELECSYS PROBNP IMMUNOASSAY | Roche Diagnostics Corp. | 2003-11-12 | Traditional | PDF ↗ |
| K032525 | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | Bayer Healthcare, LLC | 2003-09-09 | Special | PDF ↗ |
| K031038 | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | Bayer Healthcare, LLC | 2003-06-23 | Traditional | PDF ↗ |
| K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL | Biosite Incorporated | 2003-02-21 | Special | PDF ↗ |
| K022516 | ELECSYS PROBNP IMMUNOASSAY | Roche Diagnostics Corp. | 2002-11-19 | Traditional | PDF ↗ |
| K021317 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Biosite Incorporated | 2002-07-01 | Traditional | PDF ↗ |
| K010266 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 | Biosite Incorporated | 2001-03-16 | Traditional | PDF ↗ |
| DEN000010 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Biosite Incorporated | 2000-11-20 | Post-NSE | — |
Product code NBC · Class II · Clinical Chemistry. Data: openFDA.