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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, test, vitamin d
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 21 21
2018 75 75
2019 38 38
2020 10 10
2021 15 15
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 108 108
Non Reproducible Results 28 28
Incorrect Or Inadequate Test Results 11 11
Low Test Results 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Device Damaged Prior to Use 2 2
Incorrect Measurement 2 2
Unable to Obtain Readings 2 2
High Readings 2 2
Low Readings 2 2
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 91 91
No Known Impact Or Consequence To Patient 54 54
No Clinical Signs, Symptoms or Conditions 16 16
No Patient Involvement 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Qualigen Inc II Sep-07-2017
3 R & D Systems, Inc. III Nov-09-2018
4 Roche Diagnostics Corporation II Jul-08-2018
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