Product Description
FDA-cleared specimen collection and transport
Bioer Sample Preservative Fluid, Cat. BSC82X1-A1, is cleared by the FDA under 510(k) K222771 for the stabilization, transportation and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the fluid are stable refrigerated at 2-8 °C and at room temperature at 20-25 °C, and the medium is suitable for use with compatible legally marketed molecular diagnostic devices.
Why laboratories choose it
- Inactivation at collection — rapidly inactivates virus in the specimen, reducing exposure risk for collection staff and couriers.
- Nucleic acid protection — formulated to inhibit DNase and RNase activity so target nucleic acid stays intact through transport and hold times.
- No cold chain required — validated stability at both 2-8 °C and 20-25 °C simplifies courier logistics and satellite collection sites.
- Ready-to-use collection set — 2 mL of fluid in a 5 mL screw-cap tube, paired with an individually wrapped sterile nasopharyngeal swab.
- Workflow compatible — feeds directly into magnetic-bead extraction and real-time RT-PCR workflows, including Bioer MagaBio extraction kits and Bioer real-time PCR instruments.
- High-volume packaging — bag of 100 complete sets for collection programs, with bulk configurations available on request.
Specifications
| Catalog number | BSC82X1-A1 |
| Medium volume | 2 mL |
| Tube | 5 mL, screw cap |
| Swab included | Sterile nasopharyngeal swab, individually wrapped |
| Pack size | 100 collection sets per bag |
| Storage and transport | 2-8 °C or 20-25 °C |
| Specimen type (cleared) | Unprocessed upper respiratory specimens |
| Manufacturer | Hangzhou Bioer Technology Co., Ltd. |
| FDA classification | Class II, 21 CFR 866.2950, product code QBD |
| 510(k) number | K222771, cleared June 26, 2024 |
What's in the box
100 x Bioer Sample Preservative Fluid, 2 mL in 5 mL tube, each with one sterile nasopharyngeal swab.
Regulatory statement
Cat. BSC82X1-A1 is cleared under FDA 510(k) K222771 as a Class II Microbial Nucleic Acid Storage and Stabilization Device, 21 CFR 866.2950, product code QBD, with the Indications for Use stated above. Other Bioer BSC82 configurations, including bulk bottles and alternative tube volumes and oropharyngeal-swab kits, are not included in K222771 and are supplied in the United States for research use only, not for use in diagnostic procedures. Clinical laboratories are responsible for validating the transport medium with their own assay under CLIA. Manufactured by Hangzhou Bioer Technology Co., Ltd. Distributed by Pro Lab Supply Corp, authorized distributor.
