OZF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tissue Rna Preservative For Collection, Storage, And Transportation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4070
- Medical specialty
- Immunology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| RNARETAIN (K113420) | Asuragen, Inc. | 2012-03-16 |
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