Contract manufacturerSIGMA-ALDRICH MANUFACTURING, LLC (St. Louis, MO)MissouriImmunologyHematologyPathologyClass IIClass IIIClass I
SIGMA-ALDRICH MANUFACTURING, LLC
Contract manufacturer ยท St. Louis, MO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1938173 (openFDA record; or search FDA's registration database)
- FEI number
- 1938173
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- MilliporeSigma (FDA owner/operator no. 1216103)
- Registered address
- 545 SOUTH EWING AVE., St. Louis, MO 63103
- Contract listings
- 6 device listings, 5 product codes, first listed Dec 2, 2002
- 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 |
|---|---|---|---|---|---|
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | Class II | Immunology | Contract manufacturing | Jan 28, 2016 |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | Class II | Hematology | Contract manufacturing | Jan 28, 2016 |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | Class III | Pathology | Contract manufacturing | Jul 6, 2018 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Dec 2, 2002 |
| SBB | System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | Class III | Pathology | Contract manufacturing | Feb 7, 2025 |