Healthcare firm Cardinal Health of Dublin, OH, said its Nuclear Associates subsidiary has received U. S. Food and Drug Administration 510(k) clearance for its CalRad Mark VI Dose Calibrator.
The unit features a touch-screen interface; embedded Microsoft Windows XP; ±1% electrometer accuracy; built-in, menu-driven software for automated linearity, using the decay or sleeve method, according to the firm. There are also geometry, accuracy, constancy, molybdenum breakthrough and system checks; quality assurance protocols for daily and quarterly checks; kit inventory control for remembering activity and volume in prepared kits; and an extensive isotope library, according to the firm.
In related news, Nuclear Associates has received has successfully achieved National Voluntary Laboratory Accreditation Program (NVLAP) accreditation for its global calibration laboratory by the U.S. National Institute of Standards and Technology (NIST).
The NIST-administered accreditation, administered by NIST, certifies that the company’s global calibration laboratory operates in accordance with NVLAP management and technical requirements pertaining to quality systems, personnel, accommodation and environment, test and calibration methods, and several other measures: equipment, measurement traceability, sampling, handling of test and calibration items, and test and calibration reports, Cardinal Health said.
By AuntMinnie.com staff writersSeptember 25, 2003
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