Nova Biomedical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 19 (13 Class I)
- 510(k) Clearances
- 40
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0681-2025 | Class I | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose | November 20, 2024 |
| Z-0682-2025 | Class I | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood | November 20, 2024 |
| Z-0683-2025 | Class I | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription u | November 20, 2024 |
| Z-0208-2024 | Class II | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, pl | September 18, 2023 |
| Z-0207-2024 | Class II | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH | September 18, 2023 |
| Z-2732-2017 | Class II | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer P | June 19, 2017 |
| Z-0650-2014 | Class II | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System | October 10, 2013 |
| Z-1906-2013 | Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product | July 15, 2013 |
| Z-1902-2013 | Class I | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The N | July 15, 2013 |
| Z-1898-2013 | Class I | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max | July 15, 2013 |
| Z-1900-2013 | Class I | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The | July 15, 2013 |
| Z-1904-2013 | Class I | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose | July 15, 2013 |
| Z-1897-2013 | Class I | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova M | July 15, 2013 |
| Z-1899-2013 | Class I | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Ma | July 15, 2013 |
| Z-1905-2013 | Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: | July 15, 2013 |
| Z-1901-2013 | Class I | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into N | July 15, 2013 |
| Z-1903-2013 | Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The No | July 15, 2013 |
| Z-1154-2013 | Class II | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) | February 25, 2013 |
| Z-1153-2013 | Class II | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | February 25, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251281 | Nova Max Creat eGFR Monitoring System | January 21, 2026 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | January 9, 2026 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | November 22, 2024 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | November 19, 2024 |
| K232075 | StatStrip Glucose Hospital Meter System | February 23, 2024 |
| K221900 | Stat Profile Prime Plus Analyzer System | September 29, 2023 |
| K203549 | Nova Primary Glucose Analyzer System | October 18, 2022 |
| K200403 | Stat Profile Prime Plus Analyzer System | April 14, 2020 |
| K200204 | Stat Profile Prime Plus Analyzer System | April 6, 2020 |
| K200349 | Stat Profile Prime Plus Analyzer System | March 13, 2020 |
| K193246 | Stat Profile Prime Plus Analyzer System | January 24, 2020 |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | August 16, 2019 |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | July 19, 2019 |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | December 13, 2018 |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | December 13, 2018 |
| K180340 | Stat Profile Prime Plus Analyzer System | September 26, 2018 |
| K180186 | Stat Profile Prime Plus Analyzer System | August 23, 2018 |
| K180428 | Stat Profile Prime Plus Analyzer System | August 15, 2018 |
| K173797 | Stat Profile Prime Plus Analyzer System | July 17, 2018 |
| K181043 | StatStrip Glucose Hospital Meter System | July 12, 2018 |