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Test ID: FMYOP    
MyoMarker Panel 2

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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 panel was developed and its performance characteristics validated by RDL. There is no FDA approved assay for the above tests. As a lab developed test (LDT), approval or clearance by the FDA is not required. This test may be used for clinical purposes and should not be regarded as investigational or for research.

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.

83516/Mi-2

83516/PL-12

83516/PL-7

83516/EJ

83516/OJ

83516/SRP

83516/Ku

83516/U2 snRNP

83516/Anti-PM/Scl Ab

86235/Anti-Jo 1 Ab

 

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
Z2036Mi-2In Process
Z2007PL-12In Process
Z2006PL-7In Process
Z2008EJIn Process
Z2009OJIn Process
Z2034SRPIn Process
Z2010KuIn Process
Z2033U2 snRNPIn Process
Z1586Anti-PM/Scl AbIn Process
Z1588Anti-Jo-1 AbIn Process

LOINC and CPT codes are provided by the performing laboratory.