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Radioimmunoassay, Human Placental Lactogen

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1585
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1585 Human placental lactogen test system

§ 862.1585 Human placental lactogen test system.

(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.

Radioimmunoassay, Human Placental Lactogen

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1585
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1585 Human placental lactogen test system

§ 862.1585 Human placental lactogen test system.

(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.