| Device Type ID | 3419 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Regulation Description | Mumps Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.3380 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LJY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3419 |
| Device | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Product Code | LJY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mumps Virus Serological Reagents. |
| CFR Regulation Number | 866.3380 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Diamedix Corporation | III | Jul-28-2018 |
| 2 | Diamedix Corporation | II | May-16-2016 |