Attn: All Wisconsin Providers Performing Laboratory Testing on the Abbott i-STAT
Abbott i-STAT Product Notification
This notification is for providers performing laboratory testing using the Abbott i-STAT Chem8+ cartridges (blue) and CG4+ cartridges (blue). These cartridges have not obtained approval from the Food and Drug Administration (FDA) and therefore are not classified as waived testing but rather high complexity testing.
For product questions and additional information of all products affected, please contact Abbott Point of Care Technical Support through their website at www.pointofcare.abbott.
For regulatory questions please contact the Center for Medicare and Medicaid Services (CMS) at LabExcellence@cms.hhs.gov.
|
