FDA Registration
Active
🇺🇸 United States
Tumor Marker QSure Control - Tri-Level (Ref TMC-300)
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MONOBIND, INC.
- Registration Number
- 2020726
- FEI Number
- 2020726
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 N. POINTE DR.
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Owner / Operator
- Firm Name
- MONOBIND, INC.
- Operator Number
- 2020726
- Address
- 100 N. POINTE DR., --
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- Alicia Jerome
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2024-01-19 |
Proprietary Names
Tumor Marker QSure Control - Tri-Level (Ref TMC-300)
Tg QSure® Control - Tri-Level (Ref TG-300)
Maternal QSure® Control - Tri-Level (Ref MC-300)
TBG QSure® Control - Tri-Level (Ref TBG-300)
Multi-Ligand QSure® Control - Tri-Level (Ref ML-300, ML-300A, ML-300B)
Anti-H. Pylori QSure Control - Positive & Negative (Ref HPC-300)
Anti-Tg & Anti-TPO QSure® Control - Positive & Negative (Ref AIT-101)
Establishment Types
Manufacture Medical Device