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BIOFIRE DIAGNOSTICS LLC

✅ Low Risk

FEI: 3014357470 • Salt Lake City, UT • UNITED STATES

FEI

FEI Number

3014357470

📍

Location

Salt Lake City, UT

🇺🇸
🏢

Address

410 S Chipeta Way, , Salt Lake City, UT, United States

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/23/2020
Latest Refusal
4/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

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

DateProductViolationsDivision
4/23/2020
91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIOFIRE DIAGNOSTICS LLC's FDA import refusal history?

BIOFIRE DIAGNOSTICS LLC (FEI: 3014357470) has 1 FDA import refusal record(s) in our database, spanning from 4/23/2020 to 4/23/2020.

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. BIOFIRE DIAGNOSTICS LLC's FEI number is 3014357470.

What types of violations has BIOFIRE DIAGNOSTICS LLC received?

BIOFIRE DIAGNOSTICS LLC 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 BIOFIRE DIAGNOSTICS LLC come from?

All FDA import refusal data for BIOFIRE DIAGNOSTICS LLC 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.