BD Kiestra™ InoqulA
BD Kiestra™ InoqulA+™
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | 2025-02-18 |
| Record revised | 2025-08-04 (version 7) |
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 |
| Sizes | Width 4503 mm; height 2234 mm; depth 978 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 446973 | In distribution | |
| 447202 | Width 4503 mm | 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 |
| 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 |
| Diagnostic Automation | Diagnostic Automation, Inc. | 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 | 4 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.