This article was originally published in The Gray Sheet
Executive SummaryPerkin Elmer's Wallac biotinidase test system and substantially equivalent devices (21 CFR 862.1118) are reclassified from Class III to Class II with restriction to prescription use as a special control, following a Dec. 20 petition by the company. Biotinidase test systems are semiquantitative in vitro tests to screen infants for biotinidase deficiency
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