NBC — Test, Natriuretic Peptide Class II
FDA Device Classification
Classification Details
- Product Code
- NBC
- Device Class
- Class II
- Regulation Number
- 862.1117
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253539 | axis-shield diagnostics | Alere NT-proBNP for Alinity i | February 18, 2026 |
| K241176 | axis-shield diagnostics | Alere NT-proBNP for Alinity i Reagent Kit | January 16, 2025 |
| K232164 | beckman coulter | Access NT-proBNP | April 12, 2024 |
| K220265 | siemens healthcare diagnostics | ADVIA Centaur® NT-proBNPII (PBNPII) | September 24, 2023 |
| K223637 | roche diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | July 21, 2023 |
| K210546 | roche diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | March 31, 2022 |
| K211199 | tosoh bioscience | ST AIA-PACK BNP Assay | November 8, 2021 |
| K201312 | ortho clinical diagnostics | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | October 4, 2021 |
| K192380 | fujirebio diagnostics | ST AIA-PACK BNP | August 24, 2020 |
| K092649 | roche diagnostics | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 | February 4, 2010 |
| K082645 | siemens healthcare diagnostics | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRI | September 22, 2008 |
| K063662 | response biomedical | RAMP NT-PROBNP ASSAY | July 21, 2008 |
| K080269 | biosite incorporated | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | June 6, 2008 |
| K080578 | siemens healthcare diagnostics | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CAR | May 16, 2008 |
| K073091 | biomerieux | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | February 29, 2008 |
| K072437 | roche diagnostics | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | February 5, 2008 |
| K072189 | mitsubishi kagaku iatron | PATHFAST NTPROBNP AND D-DIMER TESTS | February 5, 2008 |
| K071834 | dade behring | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | August 17, 2007 |
| K071767 | dade behring | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | August 4, 2007 |
| K061795 | dade behring | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR | September 11, 2006 |