Cellient®
Processor for use in preparation of cell blocks from cellular material and tissue fragments in PreservCyt®.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | IDT |
| Device type | Apparatus, Melting Point, Paraffin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-14 |
| Record revised | 2024-08-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 16 to 32 °C; Storage environment temperature 0 to 36 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cellient Filter Cassette Kit | In distribution | |
| Cellient Processor | In distribution | |
| Cellient Finishing Station | In distribution |
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.