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Interesting observations: US approval five to seven years of foreign testing. Longest European delay: Germany six months. Germany re-ran all our test themselves. Shortest approval: UK. One month, accepted our test reports as gospel. Delay for paper processing. IIRC France re-ran some tests but not all. Even Italy did some tests.
The blood testing machine sold for about one million dollars but the real money was in the reagent, $10K per liter. Management continually urged us to speed up the tests so the machine would use reagent faster. Only USA & Europe paid full price for the machine. Maybe Japan. I don't recall us marketing there. Third world got it either greatly reduced or free. Still had to buy the reagent.
Abbott ID NOW CoV-2 molecular point-of-care test for novel coronavirus
May 2020: FDA Alert Inaccuracy Abbott ID NOW
PC software is the worst. "Looks like it works, push it out the door. All software has bugs." Cell phone backbone software is in between." I still remember a hard guideline from a company that shall remain nameless: "Hold onto the line as long as the billing data isn't lost. The last thing to lose is the billing data."
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