Microbial Nucleic Acid Storage And Stabilization Device
Device Code: 3586
Product Code(s):
QBD Definition: Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.
Device Classification Information
| Device Type ID | 3586 |
| Device Name | Microbial Nucleic Acid Storage And Stabilization Device |
| Physical State | Liquid Media. |
| Technical Method | Media Stores And Stabilizes Microbial Nucleic Acids. |
| Target Area | Human Samples. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.2950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3586 |
| Device | Microbial Nucleic Acid Storage And Stabilization Device |
| Product Code | QBD |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.2950 [🔎] |
TPLC Last Update: 2019-04-02 20:32:49