| Device Type ID | 3486 |
| Device Name | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Regulation Description | Trypanosoma Spp. 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 | 866.3870 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MIU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3486 |
| Device | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Product Code | MIU |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Trypanosoma Spp. Serological Reagents. |
| CFR Regulation Number | 866.3870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INBIOS INT'L INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 8 |
False Positive Result | 5 |
Low Test Results | 2 |
False Negative Result | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Wiener Laboratories | II | Mar-07-2018 |