Epredia
Cytocool™ II and Ice-It™ are intended for use in histology laboratories for rapid freezing of tissue specimens. Cytocool™ II and Ice-It™ have a boiling point of -26.5° C/-15.1° F, which…
Cytocool™ II and Ice-It™ are intended for use in histology laboratories for rapid freezing of tissue specimens. Cytocool™ II and Ice-It™ have a boiling point of -26.5° C/-15.1° F, which indicates fast freezing. These products do not cause ozone depletion and significantly reduce global warming potential. These products contain tetrafluoroethane.
Who Else Makes It
Concentrated in Hubei (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Richard-Allan Scientific LLC, United States |
|---|---|
| FDA product code | LEA |
| Device type | Preservative, Cytological |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mucolexx™ | In distribution | |
| CytoRich Red Collection Fluid | In distribution | |
| CytoRich Red Collection Fluid | In distribution | |
| PapSpin™ Collection Fluid | In distribution | |
| Ice-It™ | In distribution | |
| Cytospin Collection Fluid | In distribution | |
| Histogel™ | In distribution | |
| Cytoblock Kit | In distribution | |
| Cytospin Collection Fluid | In distribution | |
| Saccomanno Fluid | In distribution | |
| Histogel™ Starter Kit 120V | In distribution | |
| Mucolexx™ | In distribution | |
| CytoRich Red Collection Fluid | In distribution | |
| Cytoblock Replacement Reagents | In distribution | |
| Cell-Fixx | In distribution | |
| Fix-Rite™ 2 Pump | In distribution | |
| Mucolexx™ | In distribution | |
| CytoRich Red Collection Fluid | In distribution | |
| Urine Cytology Collection System | In distribution | |
| CytoRich Red Collection Fluid | In distribution | |
| Histogel™ Starter Kit 240V | In distribution | |
| Cytospin Collection Fluid | In distribution | |
| Histogel™ | In distribution | |
| Cytospin Collection Fluid | In distribution | |
| PapSpin™ Collection Fluid Kit B1001407 sold only as part of Shandon™ PapSpin™ K | In distribution | |
| Saccomanno Fluid | In distribution | |
| Cytocool™ II | In distribution | |
| PapSpin™ Collection Fluid | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PathTezt® | Biocytech Corporation SDN BHD | 17 |
| ThinPrep | Hologic, Inc. | 12 |
| Streck Cell Preservative | Streck LLC | 4 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 2 |
| BD CytoRich™ Clear Preservative | Becton, Dickinson AND Company | 1 |
| MES: Freeze Medium | Lonza Walkersville, Inc. | 1 |
| Pre-prcs Prtm Frz Sol 131P0103, 50L drum | Lonza Walkersville, Inc. | 1 |
| Supmedic | Supmedics Inc. | 1 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-04-29 | Class II | Material/Component Contamination | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. | 506 cases = 20 of Product Code 44041; 37 of Product Code 440 | 2016-03-09 |
| 2015-04-29 | Class II | Material/Component Contamination | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. | Product 76166- 116; Product Code 76167-29 | 2016-03-09 |
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.