QHS · Anti-Human Globulin
Hematology · 21 CFR 660.50 · Class U
Overview
| Product Code | QHS |
|---|---|
| Device Name | Anti-Human Globulin |
| Regulation | 21 CFR 660.50 |
| Device Class | Class U |
| Review Panel | Hematology |
Identification
The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4). The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
