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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device igm, antigen, antiserum, control
Regulation Description Immunoglobulin (light chain specific) immunological test system.
Product CodeDFT
Regulation Number 866.5550
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Installation-Related Problem 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Dec-03-2022
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