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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, benzodiazepine
Regulation Description Benzodiazepine test system.
Product CodeJXM
Regulation Number 862.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 2
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PSYCHEMEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 4 4
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 8
High Test Results 3 3
False Negative Result 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 OraSure Technologies, Inc. III Aug-24-2020
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