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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, cocaine and cocaine metabolites
Product CodeDIO
Regulation Number 862.3250
Device Class 2


Premarket Reviews
ManufacturerDecision
CAROLINA LIQUID CHEMISTRIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDTEST DX
  SUBSTANTIALLY EQUIVALENT 1
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 12 12
2019 22 22
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 33 33
False Negative Result 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ameditech Inc II Sep-30-2020
2 OraSure Technologies, Inc. III Apr-18-2018
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