Definition: A Manual Blood Grouping And Antibody Test System Is Used To Group Red Blood Cells And To Detect Antibodies To Blood Group Antigens.
Device Type ID | 2442 |
Device Name | Manual Blood Grouping And Antibody Test Systems |
Physical State | Solid |
Technical Method | Manual |
Target Area | IVD |
Regulation Description | Automated Blood Grouping And Antibody Test System. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(k) |
CFR Regulation Number | 864.9175 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | PBC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2442 |
Device | Manual Blood Grouping And Antibody Test Systems |
Product Code | PBC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Automated Blood Grouping And Antibody Test System. |
CFR Regulation Number | 864.9175 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
BIO-RAD MEDICAL DIAGNOSTICS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
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False Negative Result | 1 |
Total Device Problems | 1 |