Serotonin Release Assay, Unfractionated Heparin
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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 BloodCenter of Wisconsin. It has not been cleared or approved by the FDA. However, the FDA has determined that such clearance or approval is not necessary. The test has been validated in house and is used for clinical purposes. It should not be regarded as investigational or for research. Our Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
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.
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|
|Z0123||unfractionated heparin Low Dose||In Process|
|Z0124||unfractionated heparin High Dose||In Process|
|Z0125||unfractionated heparin Result||In Process|