Quantum®
Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set
1manufacturer
7catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
Record
| Listed by | Terumo BCT, Inc.., United States |
|---|---|
| FDA product code | KJF |
| Device type | System, Suspension, Cell Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2024-05-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep out of sunlight.; Storage environment temperature 2 to 40 °C; Special storage condition: Protect from rain |
| Packaging | Pack of 10, pack of 2, pack of 4 |
| Distribution end date | 2020-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21020 | Withdrawn | |
| 21022 | Withdrawn | |
| 21023 | Withdrawn | |
| 92000 | Withdrawn | |
| 21024 | Withdrawn | |
| 21012 | Withdrawn | |
| 21021 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G-Rex | Wilson Wolf Manufacturing LLC | 31 |
| Corning | Corning Incorporated | 17 |
| EXP-PAK | Charter Medical, LLC | 5 |
| 1L Bottle | Scinus Cell Expansion Netherlands B.V. | 1 |
| 2L MC Bottle | Scinus Cell Expansion Netherlands B.V. | 1 |
| Scinus Cell Expansion System | Scinus Cell Expansion Netherlands B.V. | 1 |
| Save-A-Tooth | Smarthealth, Inc. | 1 |
| 2L Buffer Bottle | Scinus Cell Expansion Netherlands B.V. | 1 |
| Adherent Bag | Scinus Cell Expansion Netherlands B.V. | 1 |
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.