K222771 is an FDA 510(k) clearance for the Sample Preservative Fluid. This device is classified as a Microbial Nucleic Acid Storage And Stabilization Device (Class II - Special Controls, product code QBD).
Submitted by Hangzhou Bioer Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 26, 2024, 651 days after receiving the submission on September 14, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2950. Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material..
| 510(k) Number | K222771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2022 |
| Decision Date | June 26, 2024 |
| Days to Decision | 651 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QBD - Microbial Nucleic Acid Storage And Stabilization Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2950 |
| 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. |