Contract manufacturerBECKMAN COULTER, INC. (Chaska, MN)MinnesotaClinical chemistryHematologyImmunologyClass IClass II
BECKMAN COULTER, INC.
Contract manufacturer · Chaska, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2122870 (openFDA record; or search FDA's registration database)
- FEI number
- 2122870
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- BECKMAN COULTER, INC. (FDA owner/operator no. 2050012)
- Registered address
- 1000 LAKE HAZELTINE DR., Chaska, MN 55318
- Contract listings
- 11 device listings, 19 product codes, first listed Jun 17, 1988
- 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 |
|---|---|---|---|---|---|
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| CDP | Radioimmunoassay, Total Triiodothyronine | Class II | Clinical chemistry | Contract manufacturing | Apr 28, 1999 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| CEW | Radioimmunoassay, Parathyroid Hormone | Class II | Clinical chemistry | Contract manufacturing | Aug 14, 2008 |
| GKL | Counter, Cell, Automated (Particle Counter) | Class II | Hematology | Contract manufacturing | Apr 9, 2019 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class II | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JIO | Blood, Occult, Colorimetric, In Urine | Class II | Hematology | Contract manufacturing | Aug 18, 2014 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Jun 17, 1988 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JRE | Refractometer For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Aug 18, 2014 |
| JZO | System, Test, Thyroid Autoantibody | Class II | Immunology | Contract manufacturing | Jun 17, 1988 |
| KQO | Automated Urinalysis System | Class I | Clinical chemistry | Contract manufacturing | Jul 16, 2014 |
| LJX | Test, Urine Leukocyte | Class I | Hematology | Contract manufacturing | Aug 18, 2014 |
| LKM | Counter, Urine Particle | Class II | Hematology | Contract manufacturing | Jul 16, 2014 |
| MRG | System, Test, Vitamin D | Class II | Clinical chemistry | Contract manufacturing | Jan 22, 2015 |