Product code NBC— Clinical Chemistry
ELECSYS PROBNP IMMUNOASSAY
- Classification name
- Test, Natriuretic Peptide
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Total cleared
- 45
- First cleared
- Most recent
Market context for product code NBC
FDA has cleared devices under product code NBC between 2000 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code NBC
Recent clearances under product code NBC
- K252169 — Access BNP II
- K253539 — Alere NT-proBNP for Alinity i
- K241176 — Alere NT-proBNP for Alinity i Reagent Kit
- K232164 — Access NT-proBNP
- K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)
- K223637 — Elecsys proBNP II, Elecsys proBNP II STAT
- K210546 — Elecsys proBNP II, Elecsys proBNP II STAT
- K211199 — ST AIA-PACK BNP Assay
- K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
- K192380 — ST AIA-PACK BNP
- K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
- K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
- K063662 — RAMP NT-PROBNP ASSAY
- K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
- K080578 — DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
- K073091 — VIDAS NT-PROBNP ASSAY, MODEL: 30 449
- K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS
- K072437 — ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
- K071834 — STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
- K071767 — DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
- K061795 — DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
- K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
- K060632 — VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
- K060964 — ARCHITECT BNP ASSAY, MODEL 8K28
- K051596 — STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
- K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
- K051382 — ELECSYS PROBNP IMMUNOASSAY
- K051787 — TRIAGE BNP TEST, MODEL 98000XR
- K051265 — ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K043228 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K043476 — STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
- K042347 — MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
- K041417 — DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
- K040425 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K033606 — ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
- K032235 — MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K033383 — TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
- K032646 — ELECSYS PROBNP IMMUNOASSAY
- K032525 — BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K031038 — ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K030286 — TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
- K022516 — ELECSYS PROBNP IMMUNOASSAY
- K021317 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K010266 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
- DEN000010 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.