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510(k) Data Aggregation
K Number
K111527Device Name
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
Manufacturer
ERAGEN BIOSCIENCES, INC.
Date Cleared
2011-08-03
(63 days)
Product Code
OQO, MAY
Regulation Number
866.3305Why did this record match?
Applicant Name (Manufacturer) :
ERAGEN BIOSCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MultiCode® -RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.
Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.
Device Description
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