AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
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]