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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825) > 862.1155—Human chorionic gonadotropin (HCG) test system.

CFR

862.1155—Human chorionic gonadotropin (HCG) test system.

(a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy— (1) Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.
(2) Classification. Class II.
(b) Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy— (1) Identification. 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.
(2) Classification. Class III.
(3) Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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