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52 FR 16122, May 1, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 862.1585
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.
(b) Classification. Class II.