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TPLC
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show TPLC since
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Device
kit, quality control for blood banking reagents
Product Code
KSF
Regulation Number
864.9650
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALBA BIOSCIENCE LIMITED
SUBSTANTIALLY EQUIVALENT
4
ALBA BIOSCIENCE LIMITED (DOING BUSINESS AS QUOTIENT)
SUBSTANTIALLY EQUIVALENT
4
AMERICAN RED CROSS
SUBSTANTIALLY EQUIVALENT
2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
SUBSTANTIALLY EQUIVALENT
3
DIAGAST
SUBSTANTIALLY EQUIVALENT
2
HEMO BIOSCIENCE
SUBSTANTIALLY EQUIVALENT
4
IMMUCOR, INC.
SUBSTANTIALLY EQUIVALENT
2
MEDION GRIFOLS DIAGNOSTICS AG
SUBSTANTIALLY EQUIVALENT
2
MICRO TYPING SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
MILLIPORE (UK) LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
4
4
2016
16
16
2017
19
19
2018
20
20
2019
10
10
2020
1
1
2022
1
1
2023
2
2
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
61
61
False Positive Result
3
3
Nonstandard Device
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Off-Label Use
2
2
Defective Device
2
2
Incorrect Or Inadequate Test Results
1
1
Chemical Spillage
1
1
No Apparent Adverse Event
1
1
Human Factors Issue
1
1
Short Fill
1
1
Insufficient Information
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
36
36
No Consequences Or Impact To Patient
28
28
No Clinical Signs, Symptoms or Conditions
3
3
No Code Available
2
2
Chemical Exposure
2
2
Patient Problem/Medical Problem
1
1
No Information
1
1
Fever
1
1
Unspecified Eye / Vision Problem
1
1
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