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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, opiates, over the counter
Regulation Description Opiate test system.
Product CodeNGL
Regulation Number 862.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLSOURCE SCREENING SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ANHUI DEEPBLUE MEDICAL TECHNOLOGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASSURE TECH., LLC
  SUBSTANTIALLY EQUIVALENT 1
CO-INNOVATION BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETERBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU CLONGENE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 4
INSTANOSIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO HIGHTOP BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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