FDA Registration
Active
🇺🇸 United States
RPI BIOSOLUTIONS
Reg #: 3025663244
·
FEI: 3025663244
·
Expires 2026
Products
11
Proprietary Names
3
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- RPI BIOSOLUTIONS
- Registration Number
- 3025663244
- FEI Number
- 3025663244
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 300 TERRACE DR. SUITE A
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
Owner / Operator
- Firm Name
- RPI BIOSOLUTIONS
- Operator Number
- 10086908
- Address
- 300 TERRACE DR. SUITE A
- City
- Mundelein
- State
- IL
- Postal Code
- 60060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | QLX | Class 2 | Microbiology | No | 2023-01-20 |
| Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test | QUM | Class 2 | Microbiology | No | 2023-01-26 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2023-01-20 |
| Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | MZP | Class 2 | Microbiology | No | 2023-01-20 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2025-06-27 |
| Hepatitis Viral B Dna Detection | MKT | Class 2 | Microbiology | No | 2023-01-20 |
| Cytomegalovirus (Cmv) Dna Quantitative Assay | PAB | Class 2 | Microbiology | No | 2022-12-21 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-01-20 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2023-01-20 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-01-20 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-01-20 |
Proprietary Names
Alinity m Diluent Solution
Alinity m Lysis Solution
PrimeStore MTM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)