Product code OZF— Immunology

RNARETAIN

Classification name: Tissue Rna Preservative For Collection, Storage, And Transportation
Device class: Class 2
Regulation: 21 CFR 866.4070
Advisory panel: Immunology
Total cleared: 1
First cleared: 2012-03-16
Most recent: 2012-03-16

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OZF under 21 CFR 866.4070, via openFDA

Market context for product code OZF

FDA has cleared 1 device under product code OZF, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OZF

Asuragen, Inc.1 clearance

Recent clearances under product code OZF

K113420 — RNARETAINAsuragen, Inc.·2012-03-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.