Epredia
The Single Cytofunnel is a disposable sample chamber with attached brown or white filter card and cap. The device allows for a single cell deposition area of 6 mm and accommodates samples…
The Single Cytofunnel is a disposable sample chamber with attached brown or white filter card and cap. The device allows for a single cell deposition area of 6 mm and accommodates samples up to 0.5ml for the white filter cards and 0.4ml for the brown filter cards. The fFilter cards are preattached and allow for different absorbency rates. Brown filter cards are optimal for scan specimens such as cerebrospinal fluid. The stainless steel Cytoclip, available separately, are used to mount the Cytofunnel to the slide for use with the Cytospin™ Cytocentrifuge. Single Cytofunnels are single use only.
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 | Richard-Allan Scientific LLC, United States |
|---|---|
| FDA product code | IFB |
| Device type | Cytocentrifuge |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UniSystem Slide-10 | In distribution | |
| Double Cytofunnel™, White | In distribution | |
| UniSystem Collection Pack | In distribution | |
| UniSystem Tubes | In distribution | |
| Filter Cards, Brown | In distribution | |
| Single Cytofunnel™, White | In distribution | |
| TPX Sample Chamber Closure Caps | In distribution | |
| Clipped Funnel Starter Kit | In distribution | |
| Coverplate, 250/CS | In distribution | |
| TPX Sample Chamber | In distribution | |
| Single Cytofunnel™, Brown | In distribution | |
| Single Cytofunnel™, White | In distribution | |
| Double Cytofunnel™, White | In distribution | |
| Uni Cap, Blue | In distribution | |
| Filter Cards, White | In distribution | |
| Coverplate, 25/PK | In distribution | |
| Cytoclip™ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Non Gyn Only ThinPrep Genesis Processor | Hologic, Inc. | 1 |
| 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
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-04 | Class III | Labeling mix-ups | Mislabeled product | 1,039 cases/40 boxes per case | 2019-06-07 |
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.