Tissue Rna Preservative For Collection, Storage, And Transportation

OZF · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.4070

Classification

FDA Product Code: OZF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.4070
Review panel: PA
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown