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It sits between medical use and general healthcare supply access

This product is a chemical reagent for *in vitro* and preclinical research applications and must not be used for human administration

Garte, S

(i) For the quality ASM performance category, a data submission must (A) Include numerator and denominator data for at least one applicable quality measure described in 512.725(b) or (c) that is not an administrative claims-based collection type and meets the data completeness requirement as specified at 512.725(f) and (B) Be submitted at the TIN/NPI level, unless the ASM participant is excepted under paragraph (f) of this section