FDA Registration
Active
🇺🇸 United States
Lusis Biosciences, Inc.
Reg #: 3024647994
·
FEI: 3024647994
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Lusis Biosciences, Inc.
- Registration Number
- 3024647994
- FEI Number
- 3024647994
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2025-09-09 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2023-06-06 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-10-08 |
Proprietary Names
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Sample Storage Reagent
Nucleic Acid Extraction-Purification Kit 2
NATCH S-F11B System
NATCH S-F11C System
Nucleic Acid Extraction-Purification Kit 3
Nucleic Acid Extraction-Purification Kit 4
Q-Vera Pico 6X qPCR Instrument; Q-Vera Prima 96 qPCR Instrument
Establishment Types
Complaint File Establishment per 21 CFR 820.198