Sample Preservative Fluid
Sample Preservative Fluid stabilizes and transports unprocessed upper respiratory specimens suspected of containing influenza A virus. It also inactivates infectious material and preserves…
Sample Preservative Fluid stabilizes and transports unprocessed upper respiratory specimens suspected of containing influenza A virus. It also inactivates infectious material and preserves viral RNA for testing with compatible molecular diagnostic devices.
The medium contains guanidine thiocyanate, Triton X-100 and nuclease free water. The BSC82X1-A1 configuration supplies 2 mL in a screw cap tube with a separately packaged sterile nasopharyngeal swab for collecting the specimen.
Listed Item
The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
Storage and Handling
The collected specimen is stable for up to 35 days at 2 to 25 degrees Celsius. The fluid itself has a 24 month shelf life in that temperature range. Each vial is for one use; the preservative fluid is not supplied sterile.
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Hangzhou Bioer Technology Co., Ltd., China |
|---|---|
| FDA product code | QBD |
| Device type | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class 2 |
| Regulation | 21 CFR 866.2950 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K222771 |
| Record published | 2024-07-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSC82X1-A1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakewe | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 12 |
| PrimeStore MTM | Longhorn Vaccines and Diagnostics LLC | 10 |
| PurSafe+ | Puritan Medical Products Company LLC | 4 |
| Magbio Genomics, Inc. | Magbio Genomics Inc. | 3 |
| eNAT® | Copan Italia | 3 |
| BioSci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 3 |
| Dtpm | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 2 |
| Zhejiang Gene Science | Zhejiang Gene Science Co., Ltd. | 2 |
| Xpert Swab Specimen Collection Kit | Cepheid | 1 |
| Bioer Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 1 |
| BioMAX | Spectrum Solutions L.L.C. | 1 |
| Molecular Transport Media (MTM) 2ml | A. L. B. LUZ | 1 |
Showing 12 of 14. All products under Microbial Nucleic Acid Storage And Stabilization Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222771 | 2024-06-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.