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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
Product CodeDIC
Regulation Number 862.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carolina Liquid Chemistries III May-02-2019
2 Lin-Zhi International Inc III May-03-2019
3 Siemens Healthcare Diagnostics, Inc. II Feb-27-2020
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