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U.S. Department of Health and Human Services

Product Classification

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Device herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples
Regulation Description Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
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.
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
Product CodePGI
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3309
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible