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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device test, cystatin c
Regulation Description Creatinine test system.
Product CodeNDY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gentian AS II Oct-13-2020
2 Tosoh Bioscience Inc II Jun-05-2018
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