BD Kiestra™ ReadA
Catalogue number 446948, listed by BD Kiestra B.V., Netherlands, under Bath, Incubators/Water, All. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shandong (5), Hunan (2), Jiangsu (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 |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
| Changsha Yingtai Instrument Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Qingdao Haier Biomedical Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 3 |
Record
| Listed by | BD Kiestra B.V., Netherlands |
|---|---|
| FDA product code | JTQ |
| Device type | Bath, Incubators/Water, All |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-14 |
| Record revised | 2025-07-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 18 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 446948 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisherbrand | Fisher Scientific Company L.L.C. | 20 |
| LW Scientific, Inc. | LW Scientific, Inc. | 15 |
| HettCube | Andreas Hettich Gmbh | 12 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 9 |
| Bath, Incubators/Water, All | Synthes Gmbh | 4 |
| Haier Biomedical | Qingdao Haier Biomedical Co., Ltd. | 3 |
| StatFax | Awareness Technology, Inc. | 2 |
| Sterrad™ | Advanced Sterilization Products Services Inc. | 2 |
| Catalina Water Bath 2000 110V Serial Number: | Hager Worldwide, Inc. | 1 |
| Biospag-SI | Agilent Technologies, Inc | 1 |
| CO2 Inkubator C200 | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 1 |
| CO2 Inkubator Labo C-Top | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 16. All products under Bath, Incubators/Water, All
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| BD Kiestra B.V. | UDI-DI | 2026-02-06 | Class II | Software Manufacturing/Software Deployment | In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connecti | 82 units (7 US, 65 OUS) |
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.