ORGENTEC Diagnostika Gmbh
⚠️ High Risk
FEI: 3003232042 • Mainz, Rhineland-palatinate • GERMANY
FEI Number
3003232042
Location
Mainz, Rhineland-palatinate
Country
GERMANYAddress
Carl-zeiss Str. 49-51, , Mainz, Rhineland-palatinate, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 7/22/2025 | 82LJMANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/22/2025 | 82LJMANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 82NHXANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is ORGENTEC Diagnostika Gmbh's FDA import refusal history?
ORGENTEC Diagnostika Gmbh (FEI: 3003232042) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2025 to 7/22/2025.
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. ORGENTEC Diagnostika Gmbh's FEI number is 3003232042.
What types of violations has ORGENTEC Diagnostika Gmbh received?
ORGENTEC Diagnostika Gmbh 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 ORGENTEC Diagnostika Gmbh come from?
All FDA import refusal data for ORGENTEC Diagnostika Gmbh 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.