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510(k) K100336

MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 by Eragen Biosciences — Product Code OQO

K100336 is an FDA 510(k) premarket notification submitted by Eragen Biosciences for the device "MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305. Eragen Biosciences has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2010
Date Received
February 5, 2010
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

  • K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (August 3, 2011)

Other clearances for product code OQO

  • K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test (February 1, 2018)
  • K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay (June 15, 2017)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K150617 — cobas HSV 1 and 2 Test (June 1, 2015)
  • K142156 — SEEGENE ANYPLEX II HSV-1/2 ASSAY (February 13, 2015)
  • K142738 — artus HSV-1/2 QS-RGQ MDx Kit (December 19, 2014)
  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K140029 — AMIPLIVUE HSV 1&2 ASSAY (March 26, 2014)
  • K111951 — ISOAMP HSV ASSAY (September 27, 2011)
  • K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (August 3, 2011)

FDA data resources