Non Gyn Only ThinPrep Genesis Processor
Processes Non Gyn specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Hubei (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | IFB |
| Device type | Cytocentrifuge |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3300 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-07-31 |
| Record revised | 2024-11-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-01-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Non Gyn Only ThinPrep Genesis Processor | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 17 |
| Epredia | Shandon Diagnostics Limited | 13 |
| Thermo Fisher | Shandon Diagnostics Limited | 9 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 6 |
| Cyto-Tek® 2500 | Sakura Finetek U.S.A., Inc. | 3 |
| Slide carrier | Andreas Hettich Gmbh | 2 |
| Cytopro Dual Cytopad, fast, white, pack of 100 | ELITechGroup Inc | 1 |
| Dual Sample Chambers w/ fast,white pads,caps,48 | ELITechGroup Inc | 1 |
| Cytopro Dual Sample Chamber Caps, Pack of 48 | ELITechGroup Inc | 1 |
| Sample Chambers w/ slow, tan Cytopads, pack of 48 | ELITechGroup Inc | 1 |
| Cytopro Cytopad, slow, tan, package of 100 | ELITechGroup Inc | 1 |
| Dual Sample Chambers w/ slow,tan pads,caps,pk/48 | ELITechGroup Inc | 1 |
Showing 12 of 24. All products under Cytocentrifuge
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.