OZF
- Product code
- OZF
- Device name
- Tissue Rna Preservative For Collection, Storage, And Transportation
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.4070
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
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.
Official FDA classification page: OZF
Classification and pathway per current FDA publications. Data from openFDA (CC0).