FDA Registration
Active
🇺🇸 United States
Alinity m STI Application Specification File
Reg #: 3005248192
·
FEI: 3005248192
·
Expires 2025
Products
4
Proprietary Names
11
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ABBOTT MOLECULAR, INC.
- Registration Number
- 3005248192
- FEI Number
- 3005248192
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1300 EAST TOUHY AVENUE
- City
- Des Plaines
- State
- IL
- ZIP
- 60018
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222379
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-08-21 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2023-08-21 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-08-21 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-08-21 |
Proprietary Names
Alinity m STI Application Specification File
Alinity m Lysis Solution
Alinity m Ethanol Solution
Alinity m Diluent Solution
Alinity m STI Amplification Reagent Kit
Alinity m STI Control Kit
Alinity m Multi-Collect Specimen Collection Kit
Alinity m Sample Prep Kit 1
Alinity m System
Alinity m Vapor Barrier Solution
Alinity m Bottle for Ethanol Use
Establishment Types
Manufacture Medical Device