Definition: For The Qualitative Detection And Differentiation Of VZV, HSV1, HSV2- DNA In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.
| Device Type ID | 3563 |
| Device Name | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Physical State | Reagent Assay Kit And Instrument |
| Technical Method | Polymerase Chain Reaction |
| Target Area | Not Applicable. 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 | 866.3309 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3563 |
| Device | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Product Code | PGI |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3309 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIAGNOSTIC HYBRIDS, INC. | ||
GRANTED | 1 | |
DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELITECHGROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN BIOSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |