Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

PGI · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3309

Classification

FDA Product Code: PGI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3309
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown