| Device Type ID | 3392 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Regulation Description | Cytomegalovirus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LFZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3392 |
| Device | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Product Code | LFZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cytomegalovirus Serological Reagents. |
| CFR Regulation Number | 866.3175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 20 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 9 |
High Test Results | 8 |
Adverse Event Without Identified Device Or Use Problem | 2 |
False Positive Result | 2 |
Incorrect Or Inadequate Test Results | 2 |
False Negative Result | 2 |
Non Reproducible Results | 1 |
| Total Device Problems | 46 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Feb-14-2017 |
| 2 | Diamedix Corporation | II | May-17-2016 |