FDA Registration
Active
🇺🇸 United States
Abbott Alinity m STI Assay
Reg #: 3012598266
·
FEI: 3012598266
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MOLECULAR TESTING LABS
- Registration Number
- 3012598266
- FEI Number
- 3012598266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14401 SE 1ST Street
- City
- Vancouver
- State
- WA
- ZIP
- 98684
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202977
Owner / Operator
- Firm Name
- Molecular Testing Labs
- Operator Number
- 10081703
- Address
- 14401 SE 1ST Street
- City
- Vancouver
- State
- WA
- Postal Code
- 98684
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-12-20 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-12-20 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2023-12-20 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-12-20 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2023-12-20 |
Proprietary Names
Abbott Alinity m STI Assay
Establishment Types
Repack or Relabel Medical Device