| Device Type ID | 3112 |
| Device Name | System, Detection, Bacterial, For Platelet Transfusion Products |
| Regulation Description | Microbial Growth Monitor. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Immunology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2560 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MZC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3112 |
| Device | System, Detection, Bacterial, For Platelet Transfusion Products |
| Product Code | MZC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microbial Growth Monitor. |
| CFR Regulation Number | 866.2560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMMUNETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERAX BIOMEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
False Negative Result | 12 |
Incorrect Or Inadequate Test Results | 2 |
Insufficient Information | 2 |
Fluid Leak | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 18 |