| Device Type ID | 2408 |
| Device Name | System, Test, Automated Blood Grouping And Antibody |
| 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 | KSZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2408 |
| Device | System, Test, Automated Blood Grouping And Antibody |
| Product Code | KSZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Blood Grouping And Antibody Test System. |
| CFR Regulation Number | 864.9175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO-RAD MEDICAL DIAGNOSTICS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 13 | |
IMMUCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO TYPING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO TYPING SYSTEMS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRATEC BIOMEDICAL UK LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Negative Result | 285 |
False Positive Result | 43 |
Inadequate Instructions For Healthcare Professional | 6 |
Inaccurate Information | 6 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Or Inadequate Test Results | 2 |
Defective Component | 2 |
Power Conditioning Problem | 1 |
Inappropriate Shock | 1 |
Sparking | 1 |
Smoking | 1 |
Electrical /Electronic Property Problem | 1 |
Occlusion Within Device | 1 |
Device Displays Incorrect Message | 1 |
Defective Device | 1 |
Electrical Wire | 1 |
Patient Data Problem | 1 |
Tube | 1 |
Air Leak | 1 |
Complete Blockage | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
| Total Device Problems | 361 |