NAL · Test, Immunoassay, Biosensor, Hcg
Clinical Chemistry · 21 CFR 862.1155 · Class 2
Overview
| Product Code | NAL |
|---|---|
| Device Name | Test, Immunoassay, Biosensor, Hcg |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K012943 | THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE | Quantech , Ltd. | Jan 18, 2002 | SESE |
| K990258 | QUANTECH TOTAL B-HCG ASSAY | Quantech , Ltd. | Dec 21, 1999 | SESE |
Top Applicants
- Quantech , Ltd. — 2 clearances
