OZF — Tissue Rna Preservative For Collection, Storage, And Transportation Class II

FDA Device Classification

Classification Details

Product Code
OZF
Device Class
Class II
Regulation Number
866.4070
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K113420asuragenRNARETAINMarch 16, 2012