FDA Registration
Active
🇺🇸 United States
Alinity m Diluent Solution
Reg #: 3025663244
·
FEI: 3025663244
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- RPI BIOSOLUTIONS
- Registration Number
- 3025663244
- FEI Number
- 3025663244
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 300 TERRACE DR. SUITE A
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202977
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 |
|---|---|---|---|---|---|
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-01-20 |
| 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 |
Proprietary Names
Alinity m Diluent Solution
Alinity m Lysis Solution
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)