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TPLC
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show TPLC since
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Device
radioimmunoassay, testosterones and dihydrotestosterone
Product Code
CDZ
Regulation Number
862.1680
Device Class
1
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
BECKMAN COULTER INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
2
BIOKIT, S.A.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K122793
LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL
...
IMMUNODIAGNOSTIC SYSTEMS LTD.
SUBSTANTIALLY EQUIVALENT
1
IMMUNOTECH S.R.O.
SUBSTANTIALLY EQUIVALENT
1
MONOBIND INC.
SUBSTANTIALLY EQUIVALENT
1
NANOENTEK USA INC.
SUBSTANTIALLY EQUIVALENT
1
QUALIGEN, INC.
SUBSTANTIALLY EQUIVALENT
2
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
ROCHE DIAGNOSTICS CORP.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
3
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
TOSOH BIOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
12
12
2015
7
7
2016
5
5
2017
12
12
2018
5
5
2019
3
3
2020
12
12
2021
7
7
2022
3
3
2023
10
10
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
53
53
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Adverse Event Without Identified Device or Use Problem
8
8
Low Test Results
8
8
Non Reproducible Results
7
7
Incorrect Measurement
5
5
Incorrect Or Inadequate Test Results
4
4
Nonstandard Device
3
3
Output Problem
2
2
High Readings
2
2
Imprecision
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Device Issue
1
1
False Positive Result
1
1
Unexpected Therapeutic Results
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
26
26
No Clinical Signs, Symptoms or Conditions
24
24
No Consequences Or Impact To Patient
15
15
No Code Available
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Insufficient Information
2
2
Nausea
1
1
Misdiagnosis
1
1
Malaise
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
May-03-2017
2
Beckman Coulter Inc.
II
Nov-22-2010
3
DRG Instruments GmbH
II
Aug-05-2019
4
DRG International, Inc.
III
Aug-15-2024
5
Qualigen Inc
II
Apr-06-2020
6
Qualigen Inc
II
Dec-19-2013
7
Siemens Healthcare Diagnostics, Inc.
II
Dec-02-2022
8
Siemens Healthcare Diagnostics, Inc.
II
Jul-13-2018
9
Siemens Healthcare Diagnostics, Inc.
II
Apr-19-2017
10
Tosoh Bioscience Inc
II
Dec-22-2018
11
Tosoh Bioscience Inc
II
Jun-05-2018
12
bioMerieux, Inc.
II
Jun-29-2017
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