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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, amphetamine
Product CodeDKZ
Regulation Number 862.3100
Device Class 2


Premarket Reviews
ManufacturerDecision
ATLAS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CARDIOVASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 2
XENTA BIOMEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Positive Result 4 4
Compatibility Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Use of Incorrect Control/Treatment Settings 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Insufficient Information 2 2
Emotional Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ameditech Inc II Sep-30-2020
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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