Abbott Diagnostics Technologies AS
⚠️ Moderate Risk
FEI: 3003045237 • Oslo, OSLO • NORWAY
FEI Number
3003045237
Location
Oslo, OSLO
Country
NORWAYAddress
Kjelsasveien 161, , Oslo, OSLO, Norway
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2010 | 82DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 11/15/2010 | 82DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 11/15/2010 | 82DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Abbott Diagnostics Technologies AS's FDA import refusal history?
Abbott Diagnostics Technologies AS (FEI: 3003045237) has 3 FDA import refusal record(s) in our database, spanning from 11/15/2010 to 11/15/2010.
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 Diagnostics Technologies AS's FEI number is 3003045237.
What types of violations has Abbott Diagnostics Technologies AS received?
Abbott Diagnostics Technologies AS 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 Diagnostics Technologies AS come from?
All FDA import refusal data for Abbott Diagnostics Technologies AS 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.