FDA Registration
Active
🇺🇸 United States
Continuous Single Culture®NX (CSCMNX)
Reg #: 3036495174
·
FEI: 3036495174
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- IRVINE SCIENTIFIC LLC
- Registration Number
- 3036495174
- FEI Number
- 3036495174
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1830 E Warner Ave
- City
- Santa Ana
- State
- CA
- ZIP
- 92705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170681
Owner / Operator
- Firm Name
- IRVINE SCIENTIFIC LLC
- Operator Number
- 10092955
- Address
- 1830 E Warner Ave
- City
- Santa Ana
- State
- CA
- Postal Code
- 92705
- Country
- US
- Correspondent
- Ashley M Werner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2025-03-10 |
Proprietary Names
Continuous Single Culture®NX (CSCMNX)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility