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The purpose is a Method Comparison Study on ABL90 FLEX PLUS for BASE Parameters in Whole Blood Samples.
The subject must be 18 years or older. [+2]
Subjects who have previously provided successful measurements of arterial or ven... [+1]
This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.
Subject must be 18 years of age or older [+3]
Subject where sample collection is evaluated by PI or designee to impose unneces... [+2]
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
Samples from subjects with current or previous signs and/or symptoms of heart fa... [+3]
Duplicate collection of samples from the same subject. [+2]
To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.
Voluntarily participate in this study and sign informed consent; [+3]
eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney dis... [+8]
The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.
Subject is 18 years of age and older [+2]
Subject, who is pregnant [+6]
