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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device enzyme immunoassay, cocaine and cocaine metabolites
Regulation Description Cocaine and cocaine metabolite test system.
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 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
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
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