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510(k) K111951

ISOAMP HSV ASSAY by Biohelix Corporation — Product Code OQO

K111951 is an FDA 510(k) premarket notification submitted by Biohelix Corporation for the device "ISOAMP HSV ASSAY". The FDA issued a decision of Substantially Equivalent on September 27, 2011. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2011
Date Received
July 8, 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.

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