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The INFINITE CFTR-31 Assay is an in vitro diagnostic device for detecting cystic fibrosis gene variants in genomic DNA, aiding in carrier and newborn screening.

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What is autogenomics infiniti cftr-31 assay?

Autogenomics Infiniti CFTR-31 assay is a genetic test used to detect variants in the CFTR gene associated with cystic fibrosis and other related disorders.

Who is required to file autogenomics infiniti cftr-31 assay?

Healthcare providers and laboratories that perform the autogenomics Infiniti CFTR-31 assay are required to file the results as part of regulatory compliance.

How to fill out autogenomics infiniti cftr-31 assay?

To fill out the autogenomics Infiniti CFTR-31 assay, clinicians or laboratory personnel must provide patient identification, relevant genetic information, and results of the assay as specified in the regulatory guidelines.

What is the purpose of autogenomics infiniti cftr-31 assay?

The purpose of the autogenomics Infiniti CFTR-31 assay is to help in the diagnosis of cystic fibrosis and determine if a patient is a carrier of CFTR gene mutations.

What information must be reported on autogenomics infiniti cftr-31 assay?

Reported information must include patient demographics, assay results, interpretation of variants, and recommendations for further testing or management.

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