FDA Registration
Active
🇺🇸 United States
PROSTATE SPECIFIC ANTIGEN (PSA) ELISA
Reg #: 3015550354
·
FEI: 3015550354
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MONOCENT INC.
- Registration Number
- 3015550354
- FEI Number
- 3015550354
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8920 Quartz Ave
- City
- Northridge
- State
- CA
- ZIP
- 91324
- Country
- US
Regulatory Submissions
- PMA Number
- P950021
Owner / Operator
- Firm Name
- Monocent Inc.
- Operator Number
- 10060554
- Address
- 8920 Quartz Ave
- City
- Northridge
- State
- CA
- Postal Code
- 91324
- Country
- US
- Correspondent
- Shervin Taheri
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2023-02-20 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2023-02-20 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2023-02-20 |
Proprietary Names
PROSTATE SPECIFIC ANTIGEN (PSA) ELISA
Establishment Types
Manufacture Medical Device