FDA Registration
Active
🇺🇸 United States
Rapid SARS-CoV-2 Antigen Test Card - Outside a hospital other clinical setting
Reg #: 3005984081
·
FEI: 3005984081
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LUMIQUICK DIAGNOSTICS, INC.
- Registration Number
- 3005984081
- FEI Number
- 3005984081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2946 SCOTT BLVD.
- City
- SANTA CLARA
- State
- CA
- ZIP
- 95054
- Country
- US
Owner / Operator
- Firm Name
- LUMIQUICK DIAGNOSTICS, INC.
- Operator Number
- 9093981
- Address
- 2946 SCOTT BLVD., --
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Chih C Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-04-12 |
Proprietary Names
Rapid SARS-CoV-2 Antigen Test Card - Outside a hospital other clinical setting
Rapid SARS-CoV-2 Antigen Test Card - for person use
Rapid SARS-CoV-2 Antigen Test Card - for lay use
Rapid SARS-CoV-2 Antigen Test Card - in community
Rapid SARS-CoV-2 Antigen Test Card
Rapid SARS-CoV-2 Antigen Test Card - a combination of clinical and non-clinical settings
Establishment Types
Complaint File Establishment per 21 CFR 820.198