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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 enzyme immunoassay, amphetamine
Regulation Description Amphetamine test system.
Product CodeDKZ
Regulation Number 862.3100
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA SCIENTIFIC DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATLAS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOPHOR DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OMEGA LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 8 8
2016 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
False Positive Result 4 4
Incorrect Or Inadequate Test Results 2 2
Low Test Results 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 6 6
Test Result 1 1
Patient Problem/Medical Problem 1 1
Dysphagia/ Odynophagia 1 1
Hyperglycemia 1 1
Nausea 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Jan-26-2018
2 Ameditech Inc II Sep-30-2020
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