Data / Medical devices / Flow Cytometric Reagents And Accessories.
Flow Cytometric Reagents And Accessories. (OYE): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Flow Cytometric Reagents And Accessories. (product code OYE, Class 2, 21 CFR 864.5220). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on October 20, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OYE
- Device class
- 2
- Regulation
- 864.5220
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 1 |
| India | 1 |
| Singapore | 1 |
| France | 1 |
| Germany | 1 |
| Switzerland | 1 |
Makers of Flow Cytometric Reagents And Accessories.
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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Miami, FL, United States | Contract manufacturer, Manufacturer | 3 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 28, 2020 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter Biotechnology (Suzhou) Co., Ltd | Suzhou Jiangsu, China | Specification developer | 1 | November 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter India Private Limited | Bengaluru (Bangalore) Urban Karnataka, India | Manufacturer | 1 | November 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Caribe, LTD | Cayey, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stratec Se | BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRATEC Switzerland AG | Beringen Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 20, 2026. 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.