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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alcohol dehydrogenase, specific reagent for ethanol enzyme method
Regulation Description Alcohol test system.
Product CodeDIC
Regulation Number 862.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
SOBER IP, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1 1
Incorrect Measurement 1 1
Suction Problem 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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