FDA Registration
Active
🇺🇸 United States
Hologic, Inc.
Reg #: 3006330030
·
FEI: 3006330030
·
Expires 2026
Products
20
Proprietary Names
36
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- Hologic, Inc.
- Registration Number
- 3006330030
- FEI Number
- 3006330030
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 445 Simarano Drive
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042290
- PMA Number
- P010013
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 |
|---|---|---|---|---|---|
| Device, Thermal Ablation, Endometrial | MNB | Class 3 | Unknown | No | 2008-04-09 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2003-01-16 |
| Reader, Cervical Cytology Slide, Automated | MNM | Class 3 | Unknown | No | 2008-01-21 |
| Processor, Cervical Cytology Slide, Automated | MKQ | Class 3 | Unknown | No | 2008-01-21 |
| Apparatus, Melting Point, Paraffin | IDT | Class 1 | Pathology | No | 2008-05-23 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2008-04-11 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2011-11-08 |
| Preservative, Cytological | LEA | Class 1 | Pathology | No | 2008-04-17 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-11-12 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2021-11-12 |
| Tracking, Soft Tissue, Intraoperative | OEW | Class 2 | Neurology | No | 2021-11-12 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-11-12 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2018-08-03 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2018-08-03 |
| Stain, Papanicolau | HZJ | Class 1 | Hematology | No | 2008-04-17 |
| Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | QYV | Class 2 | Pathology | No | 2024-02-20 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2008-04-17 |
| Cytocentrifuge | IFB | Class 1 | Pathology | No | 2008-04-11 |
| Enzyme Immunoassay, Fetal Fibronectin | LKV | Class 3 | Unknown | No | 2008-01-21 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-02-21 |
Proprietary Names
NovaSure RF Controller
NovaSure Device (Handpiece)
NovaSure EndometrialAblation System
ATEC Console
Tissue Filter
Eviva
ATEC
Needle Guides
Introducer Localization Set (ILS)
ATEC Adapters
ThinPrep 5000 Processor
ThinPrep Gynecological Slides
ThinPrep Gynecological Filters
ThinPrep 2000 Slide Processor
ThinPrep Gynecological Preservative (PreservCyt)
ThinPrep® CERV(TM) PreservCyt® Solution
ThinPrep® CERV(TM) Gynecological Filters
ThinPrep Genesis Processor
Cellient
ThinPrep Slides
ThinPrep Arcless Slides
SecurView DX
PreservCyt and CytoLyt
Acessa ProVu System
Fluent
ThinPrep Imaging System Stain
MyoSure Reach
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
ThinPrep filters
Fluent Pro Fluid Management System
ThinPrep Imaging System
ThnPrep Integrated Imager
Review Scope Manual +
ThinPrep Processor
TLiIQ Fetal Fibronectin Test
NAS
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only