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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, sedimentation rate
Regulation Description Erythrocyte sedimentation rate test.
Product CodeGHC
Regulation Number 864.6700
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 7 7
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2

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