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Test ID: FAPG    
ADmark ApoE Genotype Analysis & Interpretation (Symptomatic)

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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 Athena Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investig- ational or for research only. Athena Diagnostics is licensed under the Clinical Laboratory Improvement Amend- ments of 1988 (CLIA) to perform high complexity clinical testing. Athena Diagnostics has performed assay validation studies and has developed its laboratory protocols and operating procedures in consultation with experts in the field and in accordance with standards of the National Committee on Clinical Laboratory Standards (NCCLS).

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.

81401

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
Z2274ApoE GenotypingIn Process