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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, urea (breath or blood)
Product CodeMSQ
Regulation Number 866.3110
Device Class 1


Premarket Reviews
ManufacturerDecision
EXALENZ BIOSCIENCE LTD.
  SUBSTANTIALLY EQUIVALENT 5
HEMA METRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 3
OTSUKA PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 4 4
2016 2 2
2017 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Reaction 3 3
Hyperglycemia 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Miscarriage 1 1
Nausea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Swelling 1 1
Tachycardia 1 1
Vomiting 1 1
Burning Sensation 1 1
Tingling 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exalenz Bioscience Ltd II Oct-12-2011
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