PathTezt®
Partially removes non-diagnostic debris and excess inflammatory cells increasing the detection of epithelial cell abnormalities from the sample.
2manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Biocytech Corporation SDN BHD, Malaysia |
|---|---|
| FDA product code | LEA |
| Device type | Preservative, Cytological |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCS-200910E | In distribution | |
| PCS-200901E | In distribution | |
| PCS-200920 | In distribution | |
| NGPCS-200920 | In distribution | |
| EV-60010 | In distribution | |
| PCS-200920E | In distribution | |
| EV-61000 | In distribution | |
| EV-60005 | In distribution | |
| PCS-200903E | In distribution | |
| PCS-200905E | In distribution | |
| PCS-200910 | In distribution | |
| PCS-200901 | In distribution | |
| PCS-200905 | In distribution | |
| UCPCS-200920 | In distribution | |
| PCS-926 | In distribution | |
| PDR-1000 | In distribution | |
| PCS-200903 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 28 |
| 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 |
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.