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510(k) K111527

MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT by Eragen Biosciences, Inc. — Product Code OQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2011
Date Received
June 1, 2011
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.

Other clearances by Eragen Biosciences, Inc.

  • K100336 — MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 (May 12, 2010)

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