BD Kiestra™ InoqulA+™ TLA
Catalogue number 447213, listed by BD Kiestra B.V., Netherlands, under Device, Microtiter Diluting/Dispensing. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| PlasTAT Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | BD Kiestra B.V., Netherlands |
|---|---|
| FDA product code | JTC |
| Device type | Device, Microtiter Diluting/Dispensing |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2500 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-25 |
| Record revised | 2025-08-04 (version 6) |
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 |
|---|---|---|
| 447213 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroScan | Beckman Coulter, Inc. | 5 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 5 |
| Caplugs/Evergreen | Caplugs, Inc. | 4 |
| Wasp® | Copan Wasp | 2 |
| BD Kiestra™ InoqulA | BD Kiestra B.V. | 2 |
| Asfa Spotter | MBD Co., Ltd. | 2 |
| Pipettor Module | Copan Wasp | 2 |
| Slide Prep Evo™ | Copan Wasp | 2 |
| BIO RAD | Bio-Rad Laboratories Inc. | 1 |
| Collaborative Station | Copan Wasp | 1 |
| Remel | Remel, Inc. | 1 |
| BD Innova™ | Becton, Dickinson AND Company | 1 |
Showing 12 of 13. All products under Device, Microtiter Diluting/Dispensing
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 | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2019-07-26 | Class II | Software design | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate | 9 units | 2019-12-06 |
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.