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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
Regulation Description Vitamin D test system.
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD
  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
2016 14 14
2017 21 21
2018 75 75
2019 38 38
2020 10 10
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 106 106
Non Reproducible Results 26 26
Adverse Event Without Identified Device or Use Problem 14 14
Incorrect Or Inadequate Test Results 14 14
Low Test Results 12 12
Unable to Obtain Readings 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Device Damaged Prior to Use 2 2
Incorrect Measurement 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 100 100
No Known Impact Or Consequence To Patient 59 59
No Clinical Signs, Symptoms or Conditions 9 9
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
5 Siemens Healthcare Diagnostics, Inc II Nov-11-2016
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