FDA Registration
Active
🇺🇸 United States
CRCdx RAS Mutation Detection Kit
Reg #: 3010791816
·
FEI: 3010791816
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENTROGEN, INC
- Registration Number
- 3010791816
- FEI Number
- 3010791816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20950 Warner Center Lane, Suite B
- City
- Woodland Hills
- State
- CA
- ZIP
- 91367
- Country
- US
Regulatory Submissions
- PMA Number
- P220005
Owner / Operator
- Firm Name
- EntroGen, Inc
- Operator Number
- 10088140
- Address
- 20950 Warner Center Lane, Suite B
- City
- Woodland Hills
- State
- CA
- Postal Code
- 91367
- Country
- US
- Correspondent
- Gary Potikyan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Somatic Gene Mutation Detection System | OWD | Class 3 | Unknown | No | 2023-09-30 |
Proprietary Names
CRCdx RAS Mutation Detection Kit
Establishment Types
Manufacture Medical Device