Contract manufacturerBECKMAN COULTER, INC. (Hialeah, FL)FloridaHematologyPathologyClass IClass II
BECKMAN COULTER, INC.
Contract manufacturer ยท Hialeah, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1017835 (openFDA record; or search FDA's registration database)
- FEI number
- 1017835
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- BECKMAN COULTER, INC. (FDA owner/operator no. 2050012)
- Registered address
- 740 WEST 83RD ST., Hialeah, FL 33014
- Contract listings
- 50 device listings, 13 product codes, first listed Dec 14, 1977
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Class I | Hematology | Contract manufacturing | Dec 14, 1977 |
| GGL | Control, White-Cell | Class II | Hematology | Contract manufacturing | Dec 28, 2000 |
| GKZ | Counter, Differential Cell | Class II | Hematology | Contract manufacturing | Sep 7, 2012 |
| JCB | Detergent | Class I | Pathology | Contract manufacturing | Dec 14, 1977 |
| JPK | Mixture, Hematology Quality Control | Class II | Hematology | Contract manufacturing | Apr 6, 1999 |
| KHE | Reagent, Occult Blood | Class II | Hematology | Contract manufacturing | Dec 9, 2008 |
| KRY | Calibrator For Platelet Counting | Class II | Hematology | Contract manufacturing | Dec 28, 2000 |
| KSF | Kit, Quality Control For Blood Banking Reagents | Class II | Hematology | Contract manufacturing | Jul 21, 2008 |
| MVU | Reagents, Specific, Analyte | Class I | Pathology | Contract manufacturing | Feb 11, 2005 |
| OYE | Flow Cytometric Reagents And Accessories. | Class II | Hematology | Contract manufacturing | Apr 14, 2015 |
| PDX | Flow Cytometry Calibrator | Class II | Hematology | Contract manufacturing | Jun 27, 2017 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Jul 24, 2006 |
| PWD | Flow Cytometric Test System For Hematopoietic Neoplasms | Class II | Hematology | Contract manufacturing | Jun 30, 2017 |