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Dia.Por Diagnostic Bioprobes Srl

⚠️ High Risk

FEI: 3003036962 • Milan, Milan • ITALY

FEI

FEI Number

3003036962

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Lucio Giunio Columella 31, , Milan, Milan, Italy

High Risk

FDA Import Risk Assessment

50.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
7/9/2025
Latest Refusal
7/9/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
89.7×20%
Frequency
10.0×10%
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

5081×

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

DateProductViolationsDivision
7/9/2025
82KTOREAGENT, IMMUNOASSAY, IGG
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Dia.Por Diagnostic Bioprobes Srl's FDA import refusal history?

Dia.Por Diagnostic Bioprobes Srl (FEI: 3003036962) has 1 FDA import refusal record(s) in our database, spanning from 7/9/2025 to 7/9/2025.

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. Dia.Por Diagnostic Bioprobes Srl's FEI number is 3003036962.

What types of violations has Dia.Por Diagnostic Bioprobes Srl received?

Dia.Por Diagnostic Bioprobes Srl 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 Dia.Por Diagnostic Bioprobes Srl come from?

All FDA import refusal data for Dia.Por Diagnostic Bioprobes Srl 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.