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And perhaps already accomplished? (with FDA approval)

Don't know if they're going beyond the capabilities there, I'd have to assume they are.

"Not available for sales in the USA"

And these are point-of-care devices, not DTC devices. There are a lot of POC diagnostics devices out there and very few DTC diagnostic devices.

Huh. Well, my company performs cancer diagnostics using blood samples and we use a Medonic to get a WBC count prior to processing and image analysis.