FDA Registration
Active
🇺🇸 United States
KIT ROCHE CELL COLLECTION MEDIUM 945ML
Reg #: 2243471
·
FEI: 2243471
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCHE MOLECULAR SYSTEMS, INC.
- Registration Number
- 2243471
- FEI Number
- 2243471
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1080 US Highway 202 South
- City
- Branchburg
- State
- NJ
- ZIP
- 08876
- Country
- US
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Processor, Cervical Cytology Slide, Automated | MKQ | Class 3 | Unknown | No | 2017-10-05 |
Proprietary Names
KIT ROCHE CELL COLLECTION MEDIUM 945ML
KIT DISPENSER FOR 945ML RCCM BOTTLE
Establishment Types
Manufacture Device in the United States for Export Only