Tissue Rna Preservative For Collection, Storage, And Transportation
The Tissue RNA Preservative for Collection, Storage, and Transportation is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and molecular diagnostic testing, preserving RNA integrity during handling. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZF, with regulation number 866.4070 under the Immunology specialty, reviewed by the pathology panel.
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Basic Information
- Product Code
- OZF
- Device Class
- FDA class 2
- Regulation Number
- 866.4070
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113420 | RNARETAIN | Mar 16, 2012 | Substantially Equivalent | Asuragen, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.