6 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer
FDA Enforcement
Class II
·Terminated·Nova Biomedical Corporation·July 19, 2017
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
FDA Enforcement
Class II
·Terminated·Nova Biomedical Corporation·May 1, 2013
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
FDA Enforcement
Class II
·Terminated·Nova Biomedical Corporation·January 15, 2014
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
FDA Enforcement
Class II
·Terminated·Nova Biomedical Corporation·May 1, 2013
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
FDA Enforcement
Class II
·Ongoing·Nova Biomedical Corporation·November 8, 2023
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
FDA Enforcement
Class II
·Ongoing·Nova Biomedical Corporation·November 8, 2023