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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oral fluid drugs of abuse and alcohol test specimen collection device
Definition Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Product CodePJD
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2019 1 1
2020 3 3
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Biocompatibility 2 2
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Local Reaction 2 2
Swelling 1 1
Anaphylactoid 1 1
Anxiety 1 1
Reaction 1 1
Loss of consciousness 1 1
Chemical Exposure 1 1
Patient Problem/Medical Problem 1 1
Blister 1 1
Swelling/ Edema 1 1
Facial Nerve Paralysis 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Pain 1 1

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