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Said: : "Hi Ann, To clarify, if you perform a validation study for using the meter in any capacity that is not validated by the manufacturer, then that moves the test to HIGH complexity, not moderate. I had no other choice but to perform my own...
Said: : "Yes, I read Chapter 20. Thanks for the info!"
Said: : "Also from Chapter 20: "i-STAT's microfabrication production processes are inherently capable of creating sensors with highly reproducible characteristics. For the measurement of blood gases, electrolytes and chemistries, this means that t...
Said: : "Jessica R, go on pointofcare.abbott.com, then you can locate the electronic copy of the most recent revision of the system manual. You will want the Technical Bulletin entitled "The i-STAT System Manufacturer's Quality System Instructions...

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