FDA product code OZF: Tissue Rna Preservative For Collection, Storage, And Transportation
OZF is the FDA product code for tissue rna preservative for collection, storage, and transportation. It is a Class II device, regulated under 21 CFR 866.4070 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under OZF. The average 510(k) review took 119 days (median 119).
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.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Rna Preservative For Collection, Storage, And Transportation |
| Device class | Class II |
| Regulation | 21 CFR 866.4070 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OZF clearance
Top OZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Asuragen, Inc. | 1 | 2012-03-16 |
Most recent OZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113420 | Asuragen, Inc. | RNARETAIN | 2012-03-16 | 119 |
Recalls for OZF devices
openFDA lists no recalls for product code OZF.
Frequently asked questions
What is FDA product code OZF?
OZF is the FDA product code for tissue rna preservative for collection, storage, and transportation. It is a Class II device, regulated under 21 CFR 866.4070 and reviewed by the Pathology panel.
What device class is OZF?
Class II, regulation 21 CFR 866.4070. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZF?
Across 1 cleared submissions the average was 119 days from receipt to decision (median 119).
Which companies have the most OZF clearances?
Asuragen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OZF
- Run a recall and safety report across every OZF manufacturer
- Watch product code OZF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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