I work for a physician who wants to add a new kit to detect Group A Streptococcus from throat swabs. Where do I check to see if this kit is waived or moderate complexity?
• The CLIA website has a list of all the waived tests. • If you don’t find the kit on the waived list by name of test or manufacturer, then it is not a waived test. • You can also go online to the FDA website. This website will allow you search under the Test System/Manufacturer or the Analyte Name. It will provide the test category and the specimen type that can be used for that category.
