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Test ID: 89027    
Ki-67(MIB-1), Breast, Quantitative Immunohistochemistry, Automated

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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.

88361

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
20279Accession NumberN/A
20280Referring Pathologist/Physician46608-6
20281Ref Path/Phys Address74221-3
20282Material:N/A
20283Tissue:31208-2
20284Interpretation:In Process
20285Comment:22638-1
20286SP Signing Pathologist:N/A
20287*Previous Report Follows*N/A
20288Addendum:35265-8
20289Addendum Comment:22638-1
20290Addendum Pathologist:19139-5