AntibodyShop
⚠️ Moderate Risk
FEI: 3004174438 • Gentofte • DENMARK
FEI Number
3004174438
Location
Gentofte
Country
DENMARKAddress
Grusbakken 6-8, , Gentofte, , Denmark
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2005 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 81MTPANTIBODY TO HTLV-1, ELISA | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 81KSILECTINS AND PROTECTINS | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AntibodyShop's FDA import refusal history?
AntibodyShop (FEI: 3004174438) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 7/25/2005.
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. AntibodyShop's FEI number is 3004174438.
What types of violations has AntibodyShop received?
AntibodyShop 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 AntibodyShop come from?
All FDA import refusal data for AntibodyShop 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.