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Means, Inc. Look Inside. Complete Document. Includes all amendments and changes through Reaffirmation Notice , April Detail Summary View all details. Price USD. Single User. In Stock. Need it fast? Ask for rush delivery.
Most backordered items can be rushed in from the publisher in as little as 24 hours. Some rush fees may apply. Add to Cart. View Full Details and Buy. Complementary Documents and Links:. It does not address primary isolation media, chromogenic agars, direct antigen tests, stains, or molecular methodologies used for microbial identification; nor does it address QC of antimicrobial susceptibility tests.
The document specifies the QC responsibilities of the manufacturer, distributor, and user, and identifies conditions under which an MIS with proven reliability can qualify for streamlined QC testing.
The modified approach may be applied after the user verifies acceptable MIS performance as specified in this guideline.
Implementation of streamlined QC testing by users assumes that the MIS performance is monitored by overall quality assurance QA programs on the part of the manufacturer, distributor, and user. This document is based on United States US regulations and will also serve as a useful resource for a wider audience. It is anticipated that MA will be used extensively in the United States and internationally to reduce resources spent on excessive QC testing. Browse Publishers.
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It specifies responsibilities of the manufacturer, distributor, and user. MA includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of regulations. The streamlined QC approach was developed following an evaluation of data provided by the American Society for Microbiology for a survey conducted to determine the QC failure rates of commercial MISs. The data showed a failure rate of less than 0. This document is based on United States US regulations and will also serve as a useful resource for a wider audience. It is anticipated that MA will be used extensively in the United States and internationally to reduce resources spent on excessive QC testing. Your Alert Profile lists the documents that will be monitored.
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