Contract manufacturerRPI BIOSOLUTIONS (Mundelein, IL)IllinoisMicrobiologyImmunologyClass IIClass INot classified
RPI BIOSOLUTIONS
Contract manufacturer ยท Mundelein, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3025663244 (openFDA record; or search FDA's registration database)
- FEI number
- 3025663244
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- RPI BIOSOLUTIONS (FDA owner/operator no. 10086908)
- Registered address
- 300 TERRACE DR. SUITE A, Mundelein, IL 60060
- Contract listings
- 8 device listings, 11 product codes, first listed Dec 21, 2022
- 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 |
|---|---|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | Class II | Microbiology | Contract manufacturing | Jan 20, 2023 |
| MKT | Hepatitis Viral B Dna Detection | Class II | Microbiology | Contract manufacturing | Jan 20, 2023 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | Class I | Microbiology | Contract manufacturing | Jan 20, 2023 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Class II | Microbiology | Contract manufacturing | Jan 20, 2023 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Class II | Immunology | Contract manufacturing | Jan 20, 2023 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | Class II | Microbiology | Contract manufacturing | Dec 21, 2022 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Class II | Microbiology | Contract manufacturing | Jun 27, 2025 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Class II | Microbiology | Contract manufacturing | Jan 20, 2023 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Not classified | Microbiology | Contract manufacturing | Jan 20, 2023 |
| QLX | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | Class II | Microbiology | Contract manufacturing | Jan 20, 2023 |
| QUM | Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test | Class II | Microbiology | Contract manufacturing | Jan 26, 2023 |