FDA Registration
Active
🇺🇸 United States
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Reg #: 3024647994
·
FEI: 3024647994
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Lusis Biosciences, Inc.
- Registration Number
- 3024647994
- FEI Number
- 3024647994
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3500 Breakwater Court
- City
- Hayward
- State
- CA
- ZIP
- 94545
- Country
- US
Owner / Operator
- Firm Name
- Lusis Biosciences, Inc.
- Operator Number
- 10086722
- Address
- 3500 Breakwater Court
- City
- Hayward
- State
- CA
- Postal Code
- 94545
- Country
- US
- Correspondent
- Julia Zhou
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2023-01-05 |
Proprietary Names
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Establishment Types
Complaint File Establishment per 21 CFR 820.198