Tissue Rna Preservative For Collection, Storage, And Transportation
Device Code: 3094
Product Code(s):
OZF 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 Mole
Device Classification Information
| Device Type ID | 3094 |
| Device Name | Tissue Rna Preservative For Collection, Storage, And Transportation |
| Physical State | Consists Of Different Sized Tubes And Volumes Of Preservative Solution With A Leak Proof Polyethylene Cap. |
| Technical Method | Uses A Special Tissue Preservation Solution To Preserve And Stabilize RNA In Tissue Specimen For Transport And Later Isolation And Testing. |
| Target Area | Human Tissue Biopsy Specimen. |
| Regulation Description | RNA Preanalytical Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3094 |
| Device | Tissue Rna Preservative For Collection, Storage, And Transportation |
| Product Code | OZF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | RNA Preanalytical Systems. |
| CFR Regulation Number | 866.4070 [🔎] |
TPLC Last Update: 2019-04-02 20:23:44