Contract manufacturerSysmex America, Inc. (Buffalo Grove, IL)IllinoisClinical chemistryHematologyClass IClass II
Sysmex America, Inc.
Contract manufacturer ยท Buffalo Grove, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009495621 (openFDA record; or search FDA's registration database)
- FEI number
- 3009495621
- Registered for
- FDA registration year 2027
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- SYSMEX CORPORATION (FDA owner/operator no. 9014170)
- Registered address
- SAI - Multi-Purpose Building, 1701 Leider Lane, Buffalo Grove, IL 60089
- Contract listings
- 3 device listings, 15 product codes, first listed Jun 27, 2025
- 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 | Jun 27, 2025 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| GKB | Device, Automated Sedimentation Rate | Class I | Hematology | Contract manufacturing | Jun 27, 2025 |
| GKZ | Counter, Differential Cell | Class II | Hematology | Contract manufacturing | Jun 27, 2025 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class II | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JIO | Blood, Occult, Colorimetric, In Urine | Class II | Hematology | Contract manufacturing | Jun 27, 2025 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| JOY | Device, Automated Cell-Locating | Class II | Hematology | Contract manufacturing | Jun 27, 2025 |
| JRE | Refractometer For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| KQO | Automated Urinalysis System | Class I | Clinical chemistry | Contract manufacturing | Jun 27, 2025 |
| LJX | Test, Urine Leukocyte | Class I | Hematology | Contract manufacturing | Jun 27, 2025 |