510(k) K150617

cobas HSV 1 and 2 Test by Roche Molecular Systems, Inc. — Product Code OQO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 1, 2015
Date Received: March 10, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class: Class II
Regulation Number: 866.3305
Review Panel: MI
Submission Type

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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