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10.1016/S0140-6736(18)32261-X 33 HolmanR

Biotin (Vitamin B7 or Vitamin H), in particular, is necessary to produce keratin

Available from: Ethics declarations Conflicts of Interest The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript

Most LDTs are expected to require a 510(k) or de novo , but if the type of submission is unknown, the regulatory pathway/strategy should first be determined