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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE. 510(k) Number: K150063 B. Purpose for Submission: New Device C. Measured: Human Chorionic Gonadotrophin (HCG) D.

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What is lateral flow immunoassay?

Lateral flow immunoassay is a diagnostic test used to detect the presence of target analyte in a sample without the need for specialized and expensive equipment.

Who is required to file lateral flow immunoassay?

Medical professionals, laboratory technicians, and researchers are typically required to perform and file lateral flow immunoassays.

How to fill out lateral flow immunoassay?

To fill out a lateral flow immunoassay, follow the instructions provided in the test kit, typically involving adding the sample and reading the results after a specified period of time.

What is the purpose of lateral flow immunoassay?

The purpose of lateral flow immunoassay is to quickly and easily detect the presence and concentration of specific analytes in samples, such as pathogens or biomarkers.

What information must be reported on lateral flow immunoassay?

The results of the test, including the presence or absence of the target analyte, as well as any relevant measurements such as concentration or intensity of the signal.

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