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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device control, fecal occult blood
Definition Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
Product CodeOSL
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 1 1
Material Split, Cut or Torn 1 1

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

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