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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, slide and tube, all types, listeria monocytogenes
Regulation Description Listeria spp. serological reagents.
Product CodeGSI
Regulation Number 866.3355
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Fluid Discharge 1 1

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