Hemophilia B, Factor IX Gene Mutation Screening
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Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81405-F9 (coagulation factor IX) (eg, hemophilia B), full gene sequence
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|23776||FIX Mut Screen Reason for Referral||42349-1|
|23777||Factor IX Mutation Screen Method||49549-9|
|23778||Factor IX Mutation Screen Result||38896-7|
|23779||Factor IX Mutation Screen Interp||69049-5|
|23781||Factor IX Mut Screen Reviewed By||N/A|
LOINC and CPT codes are provided by the performing laboratory.