Data / Medical devices / Tube, Tissue Culture
Tube, Tissue Culture (KJG): 20 FDA-registered makers in 5 countries
20 establishments in 5 countries are registered with the FDA to make Tube, Tissue Culture (product code KJG, Class 1, 21 CFR 864.3010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 5, 1983, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KJG
- Device class
- 1
- Regulation
- 864.3010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| China | 11 |
| United States | 5 |
| Israel | 2 |
| Taiwan | 1 |
| Vietnam | 1 |
Makers of Tube, Tissue Culture
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemex Industrial Co., Ltd. | YUNG KANG Tainan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian Liaoning, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equashield Medical Ltd | Tefen Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equashield Medical Ltd | Migdal Tefen Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labcon, North America | Petaluma, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M.D. Japan, Ltd | Can Giuoc District Long An, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OriGen Biomedical, Inc. | Austin, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Saining Biotechnology Co.,ltd | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 5, 1983. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.