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EUA Summary: Quest COVID19 Nucleic Acid Test Collection Kit March 10, 2023 EMERGENCY USE AUTHORIZATION (EUA) SUMMARY FOR THE QUEST COVID19 NUCLEIC ACID TEST COLLECTION KIT For In vitro Diagnostic
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Quest Diagnostics gets FDA approval for certain diagnostic tests and services, allowing them to provide reliable and regulated medical testing to patients.
Entities or individuals conducting or overseeing diagnostic testing that requires FDA approval or reporting are required to file with Quest Diagnostics.
To fill out the filing with Quest Diagnostics for FDA compliance, you should provide accurate patient and test information as per the required guidelines set by the FDA and Quest Diagnostics.
The purpose is to ensure that diagnostic tests meet FDA safety and efficacy standards for public health.
Information such as test results, patient demographics, and compliance with FDA regulations must be reported.
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