Smart Biopsy™ Isolation Kit
Catalogue number CIKW10, listed by Cytogen, Inc., South Korea, under Apparatus, Automated Blood Cell Diluting. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Labyrinth Biotech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Cytogen, Inc., South Korea |
|---|---|
| FDA product code | GKH |
| Device type | Apparatus, Automated Blood Cell Diluting |
| Device class | Class 1 |
| Regulation | 21 CFR 864.5240 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-15 |
| Record revised | 2026-03-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Storage | Storage environment temperature 4 to 26 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CIKW10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CTR-S | Ctcells, Inc. | 1 |
| Cell Isolator V2 | Cytogen, Inc. | 1 |
| Ctcd | Ctcells, Inc. | 1 |
| Smart Biopsy™ Cell Isolator | Cytogen, Inc. | 1 |
| ClearCell® FX1 Unit | Biolidics Limited | 1 |
| CTCeptor | Ctcells, Inc. | 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.