WebOn January 15, 2024, Abbott sent an urgent notice to all laboratoriesusing i-STAT® devices regarding the use of their CHEM8+ and CG4+ cartridges. According to the linked bulletin, the iSTAT BLUE CHEM8+ and CG4+ cartridges are not currently FDA-clearedand do not have CLIA waived status. http://policyandorders.cw.bc.ca/resource-gallery/Documents/Lab%20and%20Pathology%20Medicine%20Archive/iSTAT1%20Aqueous%20Quality%20Control%20Procedure.pdf
Abbott Point of Care 09P31-26 - McKesson Medical-Surgical
WebCHEM8+ can be used for a wide range of patients in the Emergency Department, Critical Care and Oncology settings. EXPLORE CHEM8+ i-STAT TOTAL β-hCG The i-STAT Total β-hCG test cartridge from Abbott Point of Care is the first and only whole blood, quantitative, handheld pregnancy test available for the with-patient testing environment. WebThe CHEM8+ CARTRIDGE is a single-use, in vitro diagnostic test that combines a battery of basic metabolic tests including sodium, potassium, chloride, ionized calcium, total CO(2), glucose, blood urea nitrogen … cholecystolithiasis symptomen
TESTS GRANTED WAIVED STATUS UNDER CLIA CPT …
WebJan 15, 2024 · The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, … WebJan 17, 2024 · NEW YORK – Abbott has told its customers not to use its i-Stat Blue Chem8+ and CG4+ cartridges, following discussions with the US Food and Drug Administration. The assays are modified versions of the White i-Stat Chem8+ and CG4+ cartridges, which were both FDA cleared and CLIA-waived. WebWith i-STAT CHEM8+, healthcare professionals canned receipt chemistries, electrolytes, hematocrit plus hemoglobin playing in approximately two minutes without exit the patient's side.Incorporating i-STAT CHEM8+ early in the patient expert may help transform one take of care by empowers you to accelerate clinical decision-making and increase operational … grays peak covington ky