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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, russel viper venom
Product CodeGIR
Regulation Number 864.8950
Device Class 1


Premarket Reviews
ManufacturerDecision
DSRV, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
R2 DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3

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