cellQART®
Fluid specimen concentration filter IVD
9manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| HUA Cheng XIN Plastic Mold Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Komaspec Mechanical AND Electrical Products Manufa | Huashan Town, Huadu District | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Henan Joinkona Medical Products Stock Co., Ltd. | Pingdingshan | Henan | Contract manufacturer | 12 |
| Jiangsu Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Sabeu Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | KET |
| Device type | Filters, Cell Collection, Tissue Processing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Handling environment temperature 20 to 25 °C; Storage environment temperature 20 to 25 °C; Special storage condition: avoid direct sunlight |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| cytoQART NON-GYN (LBC) Filters | 100 | In distribution | |
| cytoQART GYN (PAP) Filters | 100 | In distribution | |
| cytoQART URINE Filters | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 51 |
| Bioseal Inc. | Bioseal | 5 |
| PathTezt® | Biocytech Corporation SDN BHD | 5 |
| cytoQ® | Sabeu Gmbh & Co. KG | 3 |
| BMP Medical Single Cytology Funnel w/ White Card | Biomedical Polymers, Inc. | 2 |
| ThinPrep | Hologic, Inc. | 2 |
| Marketlab, Inc | Marketlab Incorporated | 2 |
| BMP Medical Metal Cytology Clip | Biomedical Polymers, Inc. | 1 |
| Single Cytology Funnel w/ Brown Card | Biomedical Polymers, Inc. | 1 |
| Graft Processing Board | Cole Instruments | 1 |
| Cellpreserv Kolplast | Kolplast C I | 1 |
| Mdhc | Mdhc Life Technologies (Kunshan) Co., Ltd. | 1 |
Showing 12 of 18. All products under Filters, Cell Collection, Tissue Processing
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.