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Abbott
Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer
February 6th, 2009
Abbott announced that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analyzer. Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient's metabolic state within a few minutes. The glucose cartridge quickly delivers a patient's diagnostic blood glucose level. Creatinine is a measure and indicator of a patient's renal function right at the patient's side. The five are components of the CHEM8+ cartridge, which the FDA waived in 2007. The CHEM8+ cartridge allows a clinician to run a basic chemistry...
Source: Health Business Week (2009-02-06)
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