FDA device listing
Fastep COVID-19 Antigen Pen Home Test,Fastep COVID-19 Antigen Pen Test
FDA device listing 1900395073 · Assure Tech. (Hangzhou) Co., Ltd.
Key facts
| Proprietary names | Fastep COVID-19 Antigen Pen Home Test,Fastep COVID-19 Antigen Pen Test |
|---|---|
| Owner/operator | Assure Tech. (Hangzhou) Co., Ltd. |
| Owner/operator number | 10040710 |
| Premarket submissions | K260754 |
| Product codes | QYT |
| Device names | QYT - Over-The-Counter Covid-19 Antigen Test |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3984 |
| Review panels | Microbiology |
| Registered establishments | Assure Tech. (Hangzhou) Co., Ltd., ASSURE TECH. (HANGZHOU) CO., LTD. |
| Establishment registrations | 3009585529, 3038560224 |
| FEI numbers | 3009585529, 3038560224 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database