Facs
BD FACS™ Universal Loader
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Biotechnology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | OYE |
| Device type | Flow Cytometric Reagents And Accessories. |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-10-24 |
| Record revised | 2024-10-22 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Room Temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 662879 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Navios EX | Beckman Coulter Ireland Inc | 7 |
| BD FACSuite | Becton, Dickinson AND Company | 5 |
| BD FACSLyric | Becton, Dickinson AND Company | 4 |
| FACSCanto | Becton, Dickinson AND Company | 4 |
| Navios Analysis Software | Beckman Coulter Ireland Inc | 3 |
| FACSuite | Becton, Dickinson AND Company | 3 |
| Flow Cytometric Reagents And Accessories. | Becton, Dickinson AND Company | 3 |
| BD FACSDiva | Becton, Dickinson AND Company | 3 |
| Navios | Beckman Coulter Ireland Inc | 3 |
| BD FACSDiva™ | Becton, Dickinson AND Company | 2 |
| FACSVia | Becton, Dickinson AND Company | 2 |
| Navios tetra Software | Beckman Coulter Ireland Inc | 1 |
Showing 12 of 20. All products under Flow Cytometric Reagents And Accessories.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201814 | 2020-09-28 |
| K170974 | 2017-07-03 |
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 and Company, BD Biosciences | UDI-DI | 2018-05-16 | Class III | Nonconforming Material/Component | The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use. | 8 devices | 2018-08-13 |
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.