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?:definition
  • (a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy--A human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. (b) Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy--A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
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