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TPLC
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Device
c. difficile toxin gene amplification assay
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Product Code
OZN
Regulation Number
866.3130
Device Class
2
Premarket Reviews
Manufacturer
Decision
FOCUS DIAGNOSTICS, INC.: DBA DIASORIN MOLECULAR LLC
SUBSTANTIALLY EQUIVALENT
1
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
SUBSTANTIALLY EQUIVALENT
1
GENEPOC INC.
SUBSTANTIALLY EQUIVALENT
1
INTELLIGENT MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
LUMINEX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NANOSPHERE, INC
SUBSTANTIALLY EQUIVALENT
1
PRIMERADX
SUBSTANTIALLY EQUIVALENT
1
QIAGEN, GMBH
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORP.
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ROCHE MOLECULAR SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
4
VELA OPERATIONS USA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2021
5
5
2022
1
1
2023
2
2
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
7
7
False Positive Result
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
Insufficient Information
2
2
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Luminex Corporation
II
Jun-28-2023
2
Luminex Corporation
II
Jul-06-2022
3
Luminex Corporation
II
Aug-15-2019
4
Nanosphere, Inc.
II
Sep-23-2014
5
Nanosphere, Inc.
III
Aug-08-2014
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