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510(k) K232286

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument by Quidel Corporation — Product Code PGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
August 1, 2023
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.

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