| Device Type ID | 3396 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Regulation Description | Toxoplasma Gondii Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LGD |
| 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 | 3396 |
| Device | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Product Code | LGD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Toxoplasma Gondii Serological Reagents. |
| CFR Regulation Number | 866.3780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 228 |
False Positive Result | 108 |
Mechanical Problem | 87 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 35 |
High Test Results | 28 |
No Apparent Adverse Event | 19 |
False Negative Result | 15 |
Insufficient Information | 9 |
Device Issue | 5 |
Low Test Results | 4 |
Incorrect Or Inadequate Test Results | 2 |
Device Operational Issue | 2 |
Low Readings | 1 |
Power Problem | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 545 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-12-2018 |