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Bill West

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  • Occupation
    Data/Lab Compliance Specialist

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  1. Good Morning, Has anyone looked into this product? We're an outpatient organization with several medium-sized clinics and small school based health centers, doing non-waived testing at 3 sites (3-part diff CBCs only). We're considering this for one of our lower volume sites where the expected utilization won't justify the added regulatory overhead of upgrading our CLIA certificate. Interested to see if anyone has decided to use this yet, and what restrictions they put on its use in-house. The FDA press release states as part of its Intended Use that it is not for patients under 2 yrs of age (easy to follow), and that it is not intended "to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients". Having trouble determining what else the FDA includes in that category besides oncology and critically ill - simple iron deficiency? - sickle cell disease/trait? BW
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