| Device Type ID | 3391 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Regulation Description | Varicella-zoster 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 | 866.3900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LFY |
| 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 | 3391 |
| Device | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Product Code | LFY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Varicella-zoster Virus Serological Reagents. |
| CFR Regulation Number | 866.3900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Incorrect Or Inadequate Test Results | 2 |
False Negative Result | 2 |
| Total Device Problems | 7 |