1. No category

A1c-Cellular
®
HbA1c Control 1
Open-vial stability
30 days
350458-32
2016-08
2017-05-01
2
LOT L1 - 62980416
Instrument 3
+/-
Units4
Abbott ARCHITECT c / Integrated ci Systems
®
a
Abbott ARCHITECT i / Integrated ci Systems a
Arkray Menarini ADAMS™ A1c HA-8160
Beckman Coulter UniCel DxC 600/800 Synchron
®
®
®
Bio-Rad ® D-10™
Bio-Rad Variant II™ Turbo
Ortho-Clinical Diagnostics VITROS 5,1 FS /
4600/5600
Roche cobas® 6000/INTEGRA®
Roche cobas c 311
Siemens Healthcare Diagnostics, Inc.
Dimension Series c
2.0
11
114
22
1.0
10.6
2.0
11
92
22
1.0
10.2
2.0
1.0
mmol/mol
30
NGSP
%
4.9
IFCCb
mmol/mol
30
NGSP
%
4.9
IFCCb
mmol/mol
30
11
88
22
NGSP
%
5.0
1.0
10.9
2.0
IFCCb
mmol/mol
31
11
96
22
NGSP
%
4.8
1.0
10.7
2.0
IFCCb
mmol/mol
29
11
93
22
NGSP
%
4.8
1.0
10.4
2.0
%
IFCCb
mmol/mol
29
11
90
22
NGSP
%
4.8
1.0
10.8
2.0
IFCCb
mmol/mol
29
11
95
22
NGSP
%
4.6
1.0
10.3
2.0
mmol/mol
27
11
89
22
NGSP
%
4.3
1.0
10.6
2.0
IFCCb
mmol/mol
NGSP
%
23
4.8
11
1.0
92
10.5
22
2.0
IFCCb
mmol/mol
29
11
91
22
%
5.2
1.0
10.4
2.0
mmol/mol
33
11
90
22
IFCC
b
b
NGSP
Tosoh G7 / G8
+/12.6
4.9
NGSP
IFCC
®
LOT L2 - 62980417
IFCC
b
Total Hgb 5 , d
g/dL
11.0
12.1
g/L
110
121
Manufacturer6
Systems / Softwares7
Current Reagents8
Abbott
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Abbott
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Arkray
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Beckman Coulter
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HbA1c3
Bio-Rad
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Bio-Rad
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Ortho
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Calibrator Kit 31
Roche
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Roche
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Siemens
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1 HbA1c Control
Kontrola HbA1c / Contrôle HbA1c / HbA1c-Kontrolle / Controllo
HbA1c / HbA1c-kontroll / Control de HbA1c / HbA1c-kontroll
2 Open-vial stability 30 days
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3 Instrument
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4 Units
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5 Total Hgb
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7 Systems/Softwares
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8 Current Reagents
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intervall
The brand and product names of the instruments are trademarks of
their respective holders.
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See reverse side for important instructions.
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Streck
7002 S. 109 Street, La Vista, NE 68128 USA
EC REP
MEDIMARK® Europe
11, rue Emile Zola, BP 2332
38033 Grenoble Cedex 2, France
a Does not include the Abbott ARCHITECT i4000, c16000 or ci16200. Abbott ARCHITECT Integrated ci
Systems should use the assay values that correspond to the side either c or i that the lab is using.
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b IFCC values were calculated using the following equations:
mmol/mol HbA1c (IFCC) = [%HbA1c(NGSP)-2.152] / 0.09148
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c Abnormal assay messages may appear and can be disregarded as long as there is no change in
expected values.
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d The Total Hgb value is intended for Beckman Coulter analyzers only. The Total Hgb value is used to
calculate the HbA1c%. It should not be used to monitor the Hgb parameter.
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Hemoglobin variant peaks may occur with control materials on certain HPLC analyzers. This will not affect
the validity of results. The peaks may be disregarded if the control is performing within the assay ranges.
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