ABBOTT RAPID DIAGNOSTICS
⚠️ Moderate Risk
FEI: 3018358146 • Lake Forest, IL • UNITED STATES
FEI Number
3018358146
Location
Lake Forest, IL
Country
UNITED STATESAddress
100 Saunders Rd, , Lake Forest, IL, United States
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 8/16/2021 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/6/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ABBOTT RAPID DIAGNOSTICS's FDA import refusal history?
ABBOTT RAPID DIAGNOSTICS (FEI: 3018358146) has 3 FDA import refusal record(s) in our database, spanning from 5/6/2021 to 2/1/2022.
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. ABBOTT RAPID DIAGNOSTICS's FEI number is 3018358146.
What types of violations has ABBOTT RAPID DIAGNOSTICS received?
ABBOTT RAPID DIAGNOSTICS has been cited for 2 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 ABBOTT RAPID DIAGNOSTICS come from?
All FDA import refusal data for ABBOTT RAPID DIAGNOSTICS 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.