Barrx
Cytosponge Cell Collection Kit
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | LDZ |
| Device type | Fixative, Alcohol Containing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-06-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 131 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CYTO-KIT-USM | In distribution | |
| CYTO-KIT-R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 34 |
| Fixative, Alcohol Containing | Scientific Device Laboratory, Inc. | 7 |
| Epredia | Richard-Allan Scientific LLC | 5 |
| Camco | Cambridge Diagnostic Products, Inc. | 2 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 2 |
| Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2 |
| Chemical Service Labs, LLC | Protean Resources, LLC. | 2 |
| Alinity | Abbott Laboratories | 1 |
| Hobbs Medical Saccomanno Cell Transport System | Hobbs Medical, Inc. | 1 |
| PVA (Zn) Fix/10% Formalin 25 sets | Alpha-Tec Systems, Inc. | 1 |
| Tissue-Tek Xpress® x120 | Sakura Finetek U.S.A., Inc. | 1 |
| BD CytoRich™ Red Preservative | Becton, Dickinson AND Company | 1 |
Showing 12 of 14. All products under Fixative, Alcohol Containing
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.