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Herpes Simplex Virus Nucleic Acid Amplification Assay

Herpes Simplex Virus Nucleic Acid Amplification Assay is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Herpes Simplex Virus Nucleic Acid Amplification Assay
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OQO

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Class 2

21 CFR 866.3305

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

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