Definition: Intended For The Qualitative Detection And Differentiation Of HSV-1 And HSV-2 In Cerebrospinal Fluid (CSF) From Patients With Signs And Symptoms Of Herpes Simplex Virus (HSV) Central Nervous System (CNS) Infection. This Test Is An Aid In The Diagnosi
| Device Type ID | 3562 |
| Device Name | Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel |
| Physical State | Reagent Assay Kit And Instrument |
| Technical Method | Real-time Polymerase Chain Reaction Assay |
| Target Area | Not Applicable, The Device Is An In Vitro Diagnostic Device |
| 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 | 866.3307 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3562 |
| Device | Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel |
| Product Code | PGH |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3307 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FOCUS DIAGNOSTICS | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Focus Diagnostics Inc | I | Apr-02-2016 |