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List of evaluations

For measuring systems not available (launched) on the Scandinavian market the evaluation report can be kept confidential upon request. Confidential evaluation reports are not shown in the list below.

Evaluation #

Summary

Instrument/testkit

Component

Manufacturers

Comment

SKUP/2024/136

NO

DK

SE

EN

LabPad Evolution Ksmart CRP

CRP

Biosynex SA

SKUP/2023/130

NO

DK

SE

EN

cobas pulse

Glucose

Roche Diagnostics GmbH

SKUP/2022/131

NO

DK

SE

EN

MF-68 COVID-19 Antigen Test

SARS-CoV-2

Shenzhen Microprofit Biotech Co., Ltd.

SKUP/2022/129

NO

DK

SE

EN

Cobas b 101

HbA1c

Roche Diagnostics GmbH

SKUP/2022/128

NO

DK

SE

EN

Flowflex SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2

Acon Biotech Hangzhou Co. Ltd.

SKUP/2022/125

NO

DK

SE

EN

NADAL COVID-19 Ag Test

SARS-CoV-2

Nal von Minden GmbH

SKUP/2021/127

NO

DK

SE

EN

CLINITEST Rapid COVID-19 Antigen Test

SARS-CoV-2

Healgen Scientific Limited Liability Company/Simenes Healthineers

SKUP/2021/126

NO

DK

SE

EN

Afinion 2 Analyzer

HbA1c

Abbott Diagnostics Technologies AS

SKUP/2021/124

NO

DK

SE

EN

LumiraDx SARS-CoV-2 Ag Test

SARS-CoV-2

LumiraDx

SKUP/2021/123

NO

DK

SE

EN

qLabs Q3 Plus PT (INR) Owren (dry)

PT(INR)

Micropoint Biosience, Inc.

SKUP/2021/120

NO

DK

SE

EN

Actiste

Glucose

Brighter AB

Including user-evaluation among people with diabetes.

SKUP/2020/2018

NO

DK

SE

EN

Cobas b 101

Lipid panel

Roche Diagnostics GmbH

SKUP/2020/117

NO

DK

SE

EN

Cobas b 101

HbA1c

Roche Diagnostics GmbH

SKUP/2019/116

NO

DK

SE

EN

Cobas b 101

CRP

Roche Diagnostics GmbH

SKUP/2018/114

NO

DK

SE

EN

DIAQUICK Strep A Blue Dipstick

Strep A

DIALAB GmbH

SKUP/2017/113

NO

DK

SE

EN

Accu-Chek Instant

Glucose

Roche Diabetes Care GmbH

Including user-evaluation among people with diabetes.

SKUP/2017/112

NO

DK

SE

EN

Accu-Chek Guide

Glucose

Roche Diabetes Care GmbH

Including user-evaluation among people with diabetes.

SKUP/2016/110

NO

DK

SE

EN

Xprecia Stride Coagulation system

PT(INR)

Siemens Healthcare Diagnostics Inc.

SKUP/2015/109

NO

DK

SE

EN

MicroINR portable coagulometer

PT(INR)

iLine Microsystems S.L.

SKUP/2015/107

NO

DK

SE

EN

QuickVue Dipstick Strep A Test

Strep A

Quidel Corporation

SKUP/2015/106*

NO

DK

SE

EN

QuickRead go Strep A

Strep A

Orion Diagnostica Oy

SKUP/2014/105

NO

DK

SE

EN

Accu-Chek Aviva

Glucose

Roche Diagnostics GmbH

Including user-evaluation among people with diabetes.

SKUP/2014/104

NO

DK

SE

EN

ProTime InRhythm

PT(INR)

International Technidyne Corporation (ITC)

SKUP/2014/101

SE

EN

InnovaStar analyzer

HbA1c

DiaSys Diagnostic System

SKUP/2013/99*

NO

DK

SE

EN

Accu-Chek Mobile

Glucose

Roche Diagnostics

SKUP/2013/98*

NO

DK

SE

EN

Accu-Chek Aviva

Glucose

Roche Diagnostics

SKUP/2013/97

NO

DK

SE

EN

Cobas h 232 POC system

NT-proBNP

Roche Diagnostics GmbH

SKUP/2013/96

EN

DiaSpect Hemoglobin T System

Haemoglobin

DiaSpect Medical GmbH

SKUP/2013/92

DK

SE

EN

Eurolyser smart 700/340

CRP

Eurolyser Diagnostica GmbH

SKUP/2013/87

NO

DK

SE

EN

Wellion Calla Light

Glucose

Med Trust Handelsges.m.b.H

Including user-evaluation among people with diabetes.

SKUP/2013/85

NO

DK

SE

EN

Nova StatStrip

Glucose

Nova Biomedical Corporation

SKUP/2013/68

EN

ImmunoCap Rapid

Allergens

Phadia AB

SKUP/2013/100

NO

DK

SE

EN

mylife Unio

Glucose

Bionime Corporation

Including user-evaluation among people with diabetes.

SKUP/2012/95

NO

DK

SE

EN

Mendor Discreet

Glucose

Mendor Oy

Including user-evaluation among people with diabetes.

SKUP/2012/94

NO

DK

SE

EN

Contour XT

Glucose

Bayer HealthCare

Including user-evaluation among people with diabetes.

SKUP/2012/91

EN

Quo-Test A1c

HbA1c

Quotient Diagnostics Ltd.

SKUP/2011/93*

NO

DK

SE

EN

Accu-Chek Performa

Glucose

Roche Diagnostics

SKUP/2011/90

EN

i-Chroma

CRP

BodiTech Med.

SKUP/2011/86

NO

DK

SE

EN

OneTouch Verio

Glucose

LifeScan Inc.

Including user-evaluation among people with diabetes.

SKUP/2011/84*

NO

DK

SE

EN

Simple Simon PT and MixxoCap

PT(INR)

Zafena AB

SKUP/2011/70*

EN

Smart CRP

CRP

Eurolyser Diagnostica GmbH

SKUP/2010/89*

NO

DK

SE

EN

FreeStyle Lite

Glucose

Abbott Diabetes Care Inc.

Including user-evaluation among people with diabetes.

SKUP/2010/82

NO

SE

EN

Medi-Test Uryxon Stick

Glucose, protein, blood, laukocytes, nitrite

Macherey-Nagel GmbH & Ci. KG

SKUP/2010/81

NO

DK

SE

EN

Mylife Pura

Glucose

Bionime Corporation

Hematocrite and user-friendliness are assessed on the precursor Bionime Rightest.

SKUP/2010/80

EN

INRatio2

PT(INR)

Alere Inc.

SKUP/2010/79*

NO

SE

EN

CombiScreen 5SYS Plus urine test strip and CombiScan 100 urine analyser

Glucose, protein, blood, leukocytes, nitrite

Analyticon Biotechnologies AG

SKUP/2010/78

EN

in2it

HbA1c

Bio-Rad

SKUP/2010/73

NO

DK

SE

EN

HemoCUe WBC

Leukocytes

HemoCue AB

SKUP/2009/75

NO

DK

SE

EN

Contour

Glucose

Bayer HealthCare

Including user-evaluation among people with diabetes.

SKUP/2009/74

NO

DK

SE

EN

Accu-Chek Mobile

Glucose

Roche Diagnostics GmbH

Including user-evaluation among people with diabetes.

SKUP/2009/71

NO

DK

SE

EN

GlucoMen LX

Glucose

A. Menarini Diagnostics

Including user-evaluation among people with diabetes.

SKUP/2008/69*

DK

Diaquick Strep A test

Strep A

Dialab GmbH

SKUP/2008/66

NO

DK

SE

EN

DANA DiabeCare IISG

Glucose

SOOIL Development co. Ltd

Including user-evaluation among people with diabetes.

SKUP/2008/61

EN

i-CHROMA (nr.1)

CRP

BodiTech Med. Inc.

SKUP/2007/64

NO

DK

SE

EN

FreeStyle Lite

Glucose

Abbot Diabetes Care Inc.

Including user-evaluation among people with diabetes.

SKUP/2007/62*

DK

QuikRead Strep A test

Strep A

Orion Diagnostica Oy

SKUP/2007/59

NO

DK

SE

EN

Ascensia Breeze2

Glucose

Bayer HealthCare

Including user-evaluation among people with diabetes.

SKUP/2007/57*

NO

DK

SE

EN

Simple Simon PT

PT(INR)

Zafena AB

SKUP/2007/55

NO

EN

CoaguChek XS

PT(INR)

Roche Diagnostics

SKUP/2006/50

EN

Glucocard X-meter/X-sensor

Glucose

Arkray, Inc.

Including user-evaluation among people with diabetes.

SKUP/2006/49

EN

Precision Xtra Plus

Glucose

Abbott Laboratories

Including user-evaluation among people with diabetes.

SKUP/2006/48

NO

DK

SE

EN

Accu-Chek Sensor

Glucose

Roche Diagnostics

Including user-evaluation among people with diabetes.

SKUP/2006/46

EN

Chempaq XBC

Haematology

Chempaq AS

SKUP/2006/45

NO

HemoCue Monitor

Glucose

HemoCue AB

Including user-evaluation among people with diabetes.

SKUP/2005/52

DK

Clearview Exact Strep A Dipstick

Strep A

Applied Biotech, Inc.

SKUP/2005/51

EN

FreeStyle

Glucose

Abbot Laboratories

Including user-evaluation among people with diabetes.

SKUP/2005/44

NO

DK

SE

EN

Accu-Chek Aviva

Glucose

Roche Diagnostics

Including user-evaluation among people with diabetes.

SKUP/2005/43

NO

DK

SE

EN

Accu-Chek Compact Plus

Glucose

Roche Diagnosis

Including user-evaluation among people with diabetes.

SKUP/2005/42

DK

Twister Strep-A

Strep A

ACON laboratoriums, Inc.

SKUP/2005/40

NO

SE

EN

OneTouch GlucoTouch

Glucose

LifeScan, Johnson & Johnson

Including user-evaluation among people with diabetes.

SKUP/2005/39

NO

SE

EN

OneTouch Ultra

Glucose

LifeScan, Johnson & Johnson

Including user-evaluation among people with diabetes.

SKUP/2004/38*

SE

EN

GlucoSure Plus

Glucose

Apex Biotechnology

SKUP/2004/37*

EN

Quick response u-hCG

u-hCG

Wondsfo Biotech

SKUP/2004/36*

DK

Dtec Strep A testcard

Strep A

UltiMed

SKUP/2004/35*

EN

RapidVue u-hCG

u-hCG

Quidel Corporation

SKUP/2004/34*

EN

QuickVue u-hCG

u-hCG

Quidel Corporation

SKUP/2004/33

NO

SE

EN

Hemochron Jr. Signature

PT(INR)

ITC International Technidyne Corp

SKUP/2004/32

EN

QuickVue In-Line Strep A test

Strep A

Quidel Corporation

SKUP/2004/30

NO

SE

EN

Ascensia Contour

Glucose

Bayer Healthcare

Including user-evaluation among people with diabetes.

SKUP/2004/29

SE

Hemo-Control

Haemoglobin

EKF-diagnostic

SKUP/2003/27

DK

QuickVue Dipstick Strep A test

Strep A

Quidel Corporation

SKUP/2003/24

DK

OSOM Strep A test

Strep A

GenZyme, General Diag.

SKUP/2002/23

DK

ABX Micros CRP

Heamatology with CRP

ABX Diagnostics

SKUP/2002/22

NO

SE

GlucoMen Glycó

Glucose

Menarini Diagnostics

Including user-evaluation among people with diabetes.

SKUP/2002/21

NO

SE

FreeStyle

Glucose

TheraSense Inc.

Including user-evaluation among people with diabetes.

SKUP/2002/20

NO

SE

HemoCue 201

Glucose

Hemocue AB

SKUP/2002/19*

NO

Reagents and calibrators

PT(INR)

SKUP/2002/18

NO

SE

HemoCue

Urine-Albumin

HemoCue AB

SKUP/2001/17

SE

EN

Biotest Hb

Haemoglobin

Biotest Medizin-technik GmbH

SKUP/2001/16

NO

SE

Aution Sticks and PocketChem UA

Urine test strip

Arkray Factory Inc.

SKUP/2001/15

SE

GlucoSure

Glucose

Apex Biotechnology Corp.

SKUP/2001/14

DK

Precision Xtra

Glucose

Abbott Diabetes Care Inc.

SKUP/2001/13

NO

SE

Microsed SR-system

SR

ELECTA-LAB

SKUP/2001/12

DK

QuickRead CRP

CRP

Aidian

SKUP/2000/9

NO

Rapidpoint Coag

PT(INR)

Bayer Diagnostics

SKUP/2000/8

NO

Thrombotest/Thrombotrack

PT(INR)

Axis-Shield

SKUP/2000/7

NO

CoaguCheck S

PT(INR)

Roche Diagnostics

SKUP/2000/6

NO

Sysmex KX-21

Haematology

Sysmex Medical Electronics Co

SKUP/2000/5

DK

Accu-Check Plus

Glucose

Roche Diagnostics

SKUP/2000/11

NO

ProTime

PT(INR)

ITC International Technidyne Corp

SKUP/2000/10

NO

AvoSure PT

PT(INR)

Avocet Medical Inc.

SKUP/1999/4

NO

DCA 2000

HbA1c

Bayer Diagnostics

SKUP/1999/3

NO

NycoCard HbA1c

HbA1c

Abbott Diagnostic Technologies

SKUP/1999/2*

NO

Precision QID/Precision Plus Electrode

Glucose

Abbott Diabetes Care Inc.

SKUP/1999/1

NO

Precision G/Precision Plus Electrode

Glucose

Abbott Diabetes Care Inc.

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