| Device Type ID | 3501 |
| Device Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Regulation Description | Herpes Simplex Virus Serological Assays. |
| 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 | 866.3305 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MXJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3501 |
| Device | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Product Code | MXJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Herpes Simplex Virus Serological Assays. |
| CFR Regulation Number | 866.3305 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOKIT, S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GOLD STANDARD DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERANOS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 3 |
False Negative Result | 1 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 5 |