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
Coronavirus Antigen Detection Test System. QKP

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