21 CFR 862.1155 — System, Test, Human Chorionic Gonadotropin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1155
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. 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.
Classification Rationale
For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | 2 | 72 | 3rd Party |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 375 | 3rd Party |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 96 | 3rd Party |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 226 | 3rd Party |
| LFS | Radioreceptor Assay, Human Chorionic Gonadotropin | 2 | 0 | 3rd Party |
| NAL | Test, Immunoassay, Biosensor, Hcg | 2 | 2 | 3rd Party |
