FDA Registration
Active
🇺🇸 United States
Neisseria gonorrhoeae IVT WT Control
Reg #: 2024800
·
FEI: 2024800
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-10-31 |
Proprietary Names
Neisseria gonorrhoeae IVT WT Control
Neisseria gonorrhoeae Resistance C272T IVT Control
Epstein-Barr Virus Plasmid Control
Epstein-Barr Virus IVT Control
Varicella Zoster Virus Plasmid Control
Group A Streptococcus Plasmid Control
BK Virus Plasmid Control
Varicella Zoster Virus IVT Control
Cytomegalovirus Plasmid Control
BK Virus IVT Control
Cytomegalovirus IVT Control
Internal Control-B
Mycoplasma genitalium Controls
Establishment Types
Manufacture Medical Device