| Device Type ID | 2497 |
| Device Name | Test, Qualitative, For Hla, Non-diagnostic |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MZI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2497 |
| Device | Test, Qualitative, For Hla, Non-diagnostic |
| Product Code | MZI |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMUCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ONE LAMBDA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 96 |
Incorrect Or Inadequate Test Results | 18 |
Adverse Event Without Identified Device Or Use Problem | 10 |
False Positive Result | 8 |
Off-Label Use | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Appropriate Term/Code Not Available | 2 |
Output Problem | 1 |
Insufficient Information | 1 |
Computer Software Problem | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 146 |