FDA Registration
Active
🇺🇸 United States
Aptima Combo 2 Assay on Tigris System
Reg #: 2024800
·
FEI: 2024800
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Hologic, Inc.
- Registration Number
- 2024800
- FEI Number
- 2024800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10210 Genetic Center Dr
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200866
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- 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 | 2020-05-19 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2020-05-19 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2020-05-19 |
Proprietary Names
Aptima Combo 2 Assay on Tigris System
Aptima Combo 2 Assay on Panther system
Aptima Controls Kit
Establishment Types
Manufacture Medical Device