| Device Type ID | 3425 |
| Device Name | Antibody Igm,if, Cytomegalovirus Virus |
| Regulation Description | Cytomegalovirus 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 | 866.3175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LKQ |
| 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 | 3425 |
| Device | Antibody Igm,if, Cytomegalovirus Virus |
| Product Code | LKQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cytomegalovirus Serological Reagents. |
| CFR Regulation Number | 866.3175 [🔎] |
| Device Problems | |
|---|---|
Device Ingredient Or Reagent Problem | 27 |
Incorrect Or Inadequate Test Results | 15 |
Adverse Event Without Identified Device Or Use Problem | 7 |
False Negative Result | 5 |
False Positive Result | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
| Total Device Problems | 60 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Oct-27-2016 |