| Device Type ID | 3408 |
| Device Name | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Regulation Description | Treponema Pallidum Treponemal Test 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 | 866.3830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LIP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3408 |
| Device | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Product Code | LIP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Treponema Pallidum Treponemal Test Reagents. |
| CFR Regulation Number | 866.3830 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Bio-Rad Laboratories | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Leak / Splash | 1 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bio-Rad Laboratories | II | Jun-26-2015 |
| 2 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | III | Dec-16-2014 |