Rapigen, Inc
⚠️ Moderate Risk
FEI: 3021503587 • Suwon, Gyeonggi • SOUTH KOREA
FEI Number
3021503587
Location
Suwon, Gyeonggi
Country
SOUTH KOREAAddress
161 Saneopro155beon-Gil, Gwonseon District, Suwon, Gyeonggi, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2023 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Rapigen, Inc's FDA import refusal history?
Rapigen, Inc (FEI: 3021503587) has 3 FDA import refusal record(s) in our database, spanning from 3/1/2022 to 3/2/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Rapigen, Inc's FEI number is 3021503587.
What types of violations has Rapigen, Inc received?
Rapigen, Inc has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Rapigen, Inc come from?
All FDA import refusal data for Rapigen, Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.