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TPLC
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show TPLC since
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Device
kit, test, pregnancy, hcg, over the counter
Regulation Description
Human chorionic gonadotropin (HCG) test system.
Product Code
LCX
Regulation Number
862.1155
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACON LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
GUANGZHOU WONDFO BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUGENTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
4
4
2017
1
1
2018
2
2
2019
3
3
2020
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
7
7
False Negative Result
2
2
Incorrect, Inadequate or Imprecise Resultor Readings
1
1
Defective Device
1
1
Device Operates Differently Than Expected
1
1
Device Displays Incorrect Message
1
1
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
8
8
Insufficient Information
1
1
No Clinical Signs, Symptoms or Conditions
1
1
No Consequences Or Impact To Patient
1
1
Miscarriage
1
1
No Information
1
1
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