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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diazo (colorimetric), nitrite (urinary, non-quant)
Product CodeJMT
Regulation Number 862.1510
Device Class 1


Premarket Reviews
ManufacturerDecision
TECO DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
  1.  K100024  TECO DIAGNOSTICS UTI DETECTION STRIPS
  2.  K170118  Scanostics UTI Check Application Test System

MDR Year MDR Reports MDR Events
2018 1 1
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
High Test Results 2 2
Non Reproducible Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Universal Meditech Inc. II Oct-23-2023
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