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List of all evaluations

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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