FDA Registration
Active
🇺🇸 United States
Cocaine Metabolite 150 DAU Controls
Reg #: 3003610499
·
FEI: 3003610499
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- LIN-ZHI INTERNATIONAL, INC.
- Registration Number
- 3003610499
- FEI Number
- 3003610499
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2945 Oakmead Village Ct
- City
- Santa Clara
- State
- CA
- ZIP
- 95051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113139
Owner / Operator
- Firm Name
- LIN-ZHI INTERNATIONAL, INC.
- Operator Number
- 9049436
- Address
- 2945 Oakmead Village Court, --
- City
- Santa Clara
- State
- CA
- Postal Code
- 95051
- Country
- US
- Correspondent
- MARIE LIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2012-12-14 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2012-12-14 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2012-12-14 |
Proprietary Names
Cocaine Metabolite 150 DAU Controls
Cocaine Metabolite 150 DAU Calibrators
Cocaine Metabolite 150 Enzyme Immunoassay
Establishment Types
Manufacture Medical Device