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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k060825 B. Purpose for Submission: New device C. Measured: human Chorionic
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What is qualitative lateral flow immunoassay?
Qualitative lateral flow immunoassay is a diagnostic test that detects the presence or absence of a particular analyte.
Who is required to file qualitative lateral flow immunoassay?
Healthcare professionals or laboratories may be required to perform and file qualitative lateral flow immunoassay as part of patient diagnosis or monitoring.
How to fill out qualitative lateral flow immunoassay?
To fill out a qualitative lateral flow immunoassay, the user must follow the instructions provided in the test kit and interpret the results accordingly.
What is the purpose of qualitative lateral flow immunoassay?
The purpose of qualitative lateral flow immunoassay is to quickly and accurately determine the presence or absence of a specific analyte in a sample.
What information must be reported on qualitative lateral flow immunoassay?
The qualitative lateral flow immunoassay report must include details of the analyte being tested, the test results, and any relevant patient information.
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