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U.S. Department of Health and Human Services

Product Classification
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Device tissue rna preservative for collection, storage, and transportation
Regulation Description RNA Preanalytical Systems.
Definition The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing.
Physical State consists of different sized tubes and volumes of preservative solution with a leak proof polyethylene cap.
Technical Method Uses a special tissue preservation solution to preserve and stabilize RNA in tissue specimen for transport and later isolation and testing.
Target Area Human tissue biopsy specimen.
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeOZF
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.4070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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