GREY:LXXGQ - Post by User
Comment by
ShakeNBake20on Aug 28, 2020 3:43am
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Post# 31468286
RE:RE: Tell me lies, tell me sweet little lies
RE:RE: Tell me lies, tell me sweet little lies Ah come on letsdoit I was starting to like the change of character you had until recently! Ha but in all seriousness wouldn't the MiQLab get waived for CLIA? Under the 7 requirements I would give it a 7 maaaybe a 9 score and anything under 12 is considered moderate. But you said moderate requires to be sent to a lab but where did you see that? Below is a copy from that link you sent showing a moderate score would mean it would be waived for CLIA.
'Following categorization, a manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA.'