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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 11-dehydro thromboxane b2 kit, urinary
Definition The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
Product CodeOBW
Regulation Number 864.5700
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Image Orientation Incorrect 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Overdose 1 1
Crushing Injury 1 1
Death 1 1
Overdose 1 1
Spinal Column Injury 1 1
No Code Available 1 1

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