PFK · Quality Control For Molecular Immunohematology Tests
Hematology · 21 CFR 864.9650 · Class 2
Overview
| Product Code | PFK |
|---|---|
| Device Name | Quality Control For Molecular Immunohematology Tests |
| Regulation | 21 CFR 864.9650 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
