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REAL DIAGNOSTICS

✅ Low Risk

FEI: 3017181961 • Reisterstown, MD • UNITED STATES

FEI

FEI Number

3017181961

📍

Location

Reisterstown, MD

🇺🇸
🏢

Address

200 Business Center Dr, , Reisterstown, MD, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/4/2020
Latest Refusal
9/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1181×

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

DateProductViolationsDivision
9/4/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is REAL DIAGNOSTICS's FDA import refusal history?

REAL DIAGNOSTICS (FEI: 3017181961) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2020 to 9/4/2020.

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. REAL DIAGNOSTICS's FEI number is 3017181961.

What types of violations has REAL DIAGNOSTICS received?

REAL DIAGNOSTICS 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 REAL DIAGNOSTICS come from?

All FDA import refusal data for REAL 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.