For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor…
For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor system for automated cell cultivation. Combined with the Adherent Bag, it allows large-fold cell expansion without passing the cells due to its unique expansion technology. The SCINUS is operated by a controller, which is accessible through an integrated graphical user interface (GUI). The unique combination of the rocker, roller, and Adherent Bag ensures a homogenous environment with minimal levels of shear forces. The roller on top of the rocker enables the expansion of the available culture volume and surface area. The pH and dissolved oxygen (DO) levels are measured by integrated sensors in the Adherent Bag and are controlled with the controller software. The carboxygenator ensures that the set points are maintained within the desired bandwidths. For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The Adherent Bag contains the culture bag and the corresponding weldable tubing set. One of the unique features of the Adherent Bag is the gradual expansion of the cell culture volume. The volume can be increased from a minimal volume of 0.1 L to 1.4 L to accommodate the growing cell population.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Adherent Bag | Listed by | Scinus Cell Expansion Netherlands B.V. |
| FDA product code | KJF |
| Device type | System, Suspension, Cell Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Premarket notification | Exempt |
| Record published | 2020-12-09 |
| Record revised | 2022-06-17 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
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.