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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antisera, fluorescent, all, mycoplasma spp.
Product CodeGRZ
Regulation Number 866.3375
Device Class 1

MDR Year MDR Reports MDR Events
2023 15 15
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 20 20
High Test Results 2 2
Installation-Related Problem 1 1
Patient Data Problem 1 1
Thermal Decomposition of Device 1 1
Leak/Splash 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28

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