510(k) K162451
K162451 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Solana HSV 1+2/VZV Assay". The FDA issued a decision of Substantially Equivalent on November 28, 2016. The device falls under product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples), a Class II device regulated under 21 CFR 866.3309. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2016
- Date Received
- September 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Device Class
- Class II
- Regulation Number
- 866.3309
- Review Panel
- MI
- Submission Type
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.