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Test ID: 2C19O    
Cytochrome P450 2C19 Genotype by Sequence Analysis, Saliva

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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.

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Conditional

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.

81225-CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)

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 IDReporting NameLOINC Code
2C19QCYP2C19 SequencingIn Process
329152C19 Genotype Star AllelesIn Process
329162C19 -806C>T (*17)In Process
329172C19 1A>G (*4)In Process
329182C19 358T>C (*8)In Process
329192C19 395G>A (*6)In Process
329202C19 636G>A (*3)In Process
329212C19 681G>A (*2)In Process
329222C19 IVS5+2T>A (*7)In Process
329232C19 Reviewed byIn Process
329242C19 InterpretationIn Process