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Resulting Out PT/INR results
Someone told me about this and I want to understand if this is true or I misunderstood
I was informed that reporting out the PT results, makes a waived PT/INR device nonwaived. Is that true?
I have never heard that before.
If a device is an FDA cleared waived device, reporting the output of the device does not change the classification of the device.
If my understanding is correct, INR results are the results most clinicians use.
The PT result...
I was informed that reporting out the PT results, makes a waived PT/INR device nonwaived. Is that true?
I have never heard that before.
If a device is an FDA cleared waived device, reporting the output of the device does not change the classification of the device.
If my understanding is correct, INR results are the results most clinicians use.
The PT result...
Autilia Sisti posted a reply on Re: Technical Consultant- moderately complex te...
Monday, Oct 19, 2026 at 10:54 AM
Said: Thanks Kristine: Our Nursing Professional Development leaders have suggested Bookings. I assume we can limit how many can sign up at a time. As for the training ID, we prefer that they use their own so we can alwa...
Kristine Zinn posted a reply on Re: Technical Consultant- moderately complex te...
Monday, Oct 19, 2026 at 10:43 AM
Said: We have used Sign Up Genius for staff to sign up for training, that way we determine the number of training slots available. Now we use Microsoft Bookings. We also have a training ID set up in our middleware and we have them scan ...
Kristine Zinn posted a reply on Re: Recommended Waived PT/INR device
Monday, Oct 19, 2026 at 10:39 AM
Said: We have run into this same issue. All of the waived devices (even non-waived) I have found are stating for Coumadin/Warfarin monitoring only. Any other use would be off-label and modified FDA/LDT. We use the Coaguchek in var...
Autilia Sisti posted a reply on Re: Technical Consultant- moderately complex te...
Monday, Oct 19, 2026 at 7:58 AM
Said: Thanks for your response Aimee. Sign in meaning how do you know who is coming to the training? Making sure that too many don't come at once and allowing to give access to those who have expired in the various devices. &n...
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