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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, potentiating for in vitro diagnostic use
Product CodeKSG
Regulation Number 864.9600
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 1 1
Device Markings/Labelling Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Dec-26-2019
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