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TPLC
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Device
system, test, vitamin d
Regulation Description
Vitamin D test system.
Product Code
MRG
Regulation Number
862.1825
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC
SUBSTANTIALLY EQUIVALENT
1
IMMUNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
10
10
2021
15
15
2022
13
13
2023
22
22
2024
35
35
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
70
70
Non Reproducible Results
54
54
Low Test Results
18
18
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Low Readings
5
5
Incorrect Measurement
5
5
High Readings
4
4
Material Integrity Problem
3
3
Insufficient Information
2
2
Chemical Problem
2
2
Failure to Calibrate
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Degraded
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
81
81
No Consequences Or Impact To Patient
14
14
Insufficient Information
1
1
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