| Device Type ID | 3390 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Regulation Description | Rubella 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) |
| CFR Regulation Number | 866.3510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LFX |
| 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 | 3390 |
| Device | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Product Code | LFX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rubella Virus Serological Reagents. |
| CFR Regulation Number | 866.3510 [🔎] |
| Device Problems | |
|---|---|
Device Ingredient Or Reagent Problem | 33 |
High Test Results | 18 |
Low Test Results | 15 |
Adverse Event Without Identified Device Or Use Problem | 13 |
No Apparent Adverse Event | 6 |
Incorrect Or Inadequate Test Results | 6 |
False Negative Result | 4 |
Device Issue | 3 |
Mechanical Problem | 2 |
False Positive Result | 2 |
Low Readings | 1 |
Use Of Device Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Insufficient Information | 1 |
| Total Device Problems | 106 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Oct-13-2016 |