510(k) K103798

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS by Becton, Dickinson & CO — Product Code OQO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 18, 2011
Date Received: December 27, 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.

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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)