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510(k) Data Aggregation
K Number
K113420Device Name
RNARETAIN
Manufacturer
ASURAGEN, INC.
Date Cleared
2012-03-16
(119 days)
Product Code
OZF
Regulation Number
866.4070Why did this record match?
Product Code :
OZF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNARetain® device is a single-use, prefilled container intended for the collection, storage, and transportation of fresh breast tissue specimens for subsequent RNA isolation and further molecular diagnostic testing. For Professional Use Only.
Device Description
The RNARetain® device consists of an aqueous, hypertonic tissue preservation solution that is provided in a single-use, non-sterile vial intended to serve as the container for the collection, storage, and transport of breast tissue specimens. The ability of the solution formulation to preserve fresh tissue and nucleic acids within the tissue is due to its rapid permeation of tissue to protect cellular nucleic acids from nucleases that would otherwise rapidly degrade the nucleic acids within the specimen. The demonstrated inhibitory effect of the RNARetain® solution on the growth of bacteria, yeast and mold protects the specimen from inadvertent microbial contamination during storage or usage of the device.
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