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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device thin layer chromatography, methamphetamine
Product CodeDJC
Regulation Number 862.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
PREMIER BIOTECH INC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI VENTURE BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Irritation 1 1
Itching Sensation 1 1
Skin Irritation 1 1
No Code Available 1 1

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