an IVD that is intended for clinical use and that's designed, made, and made use of inside a one laboratory that is definitely Qualified under CLIA and fulfills the regulatory needs under CLIA to execute significant complexity tests. FDA notes that total slide imaging devices are class II units with Particular controls and so are issue to 510(k) no
an IVD that is intended for medical use and that's created, created, and made use of inside a single laboratory that may be Qualified less than CLIA and fulfills the regulatory requirements beneath CLIA to carry out substantial complexity testing. FDA notes that complete slide imaging methods are class II gadgets with Distinctive controls and are s
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