QHR · Blood Grouping Reagent
Hematology · 21 CFR 660.20 · Class U
Overview
| Product Code | QHR |
|---|---|
| Device Name | Blood Grouping Reagent |
| Regulation | 21 CFR 660.20 |
| Device Class | Class U |
| Review Panel | Hematology |
Identification
The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4). The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those 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.
