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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 radioimmunoassay, testosterones and dihydrotestosterone
Regulation Description Testosterone test system.
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 12 12
2018 5 5
2019 3 3
2020 12 12
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 31 31
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 6 6
Device Issue 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Low Test Results 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 13 13
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 10 10
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-03-2017
2 DRG Instruments GmbH II Aug-05-2019
3 Qualigen Inc II Apr-06-2020
4 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
5 Siemens Healthcare Diagnostics, Inc. II Apr-19-2017
6 Tosoh Bioscience Inc II Dec-22-2018
7 Tosoh Bioscience Inc II Jun-05-2018
8 bioMerieux, Inc. II Jun-29-2017
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