Definition: The Quality Control For Molecular Immunohematology Assay Is Used To Demonstrate That The Test Can Correctly Detect Genetic Variations Of Human Erythrocyte Antigens.
| Device Type ID | 2443 |
| Device Name | Quality Control For Molecular Immunohematology Tests |
| Physical State | DNA Or Synthetic Plasmids |
| Technical Method | Molecular |
| Target Area | N/A |
| Regulation Description | Quality Control Kit For Blood Banking Reagents. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2443 |
| Device | Quality Control For Molecular Immunohematology Tests |
| Product Code | PFK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Quality Control Kit For Blood Banking Reagents. |
| CFR Regulation Number | 864.9650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOARRAY SOLUTIONS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |