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#740 Lot.85870 Einsert

This document provides information about Lyphochek Diabetes Control Levels 1 and 2, including: - Level 1 has an average Hemoglobin A1C of 4.82% and a range of 4.16-5.48% - Level 2 has an average Hemoglobin A1C of 9.73% and a range of 8.93-10.5% - The document lists information about testing the levels using an Abbott ARCHITECT cSystems analyzer.

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jnyng222
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0% found this document useful (0 votes)
2K views5 pages

#740 Lot.85870 Einsert

This document provides information about Lyphochek Diabetes Control Levels 1 and 2, including: - Level 1 has an average Hemoglobin A1C of 4.82% and a range of 4.16-5.48% - Level 2 has an average Hemoglobin A1C of 9.73% and a range of 8.93-10.5% - The document lists information about testing the levels using an Abbott ARCHITECT cSystems analyzer.

Uploaded by

jnyng222
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Lyphochek Diabetes Control

Levels 1 and 2
Level 1 85871
740 Bilevel 6 x 0.5 mL 2026-04-30 85870 Level 2 85872
740X MiniPak 2 x 0.5 mL

https://www.myeinserts.com/85870

酸芯 裾伎 摂祢

申捷 弘 壬桁

或案

志悟禰脊 壬誓刑. 精誓脊 б丞資瀬 政鎌


愛随熊 団鰻濡州綬穣.

綬捷

刻意 弘 勝拙資

宕拙 資刈 宕資

赤対

恥拙蜘裾 瓜誓

勝責 鮮裾 酸念

• 舘瀬摘 対套 団疑裳 意祢 創綬酸念

/Korean • 2023-07 • 4037-00


Lyphochek Diabetes Control, Levels 1 and 2
懇糸悟蟻
Hemoglobin Hemoglobin A1 ❑ Hemoglobin F ❍
Hemoglobin (Total Glycated) ❑ Hemoglobin A1C

劃套
❑ 瀬 懇糸悟裾 瓜環г 京鎌 勝拙資裳 環祢 刻西髄 粧寿寒寛.
❍ г髄 摂委棄創 升数.

焦発

寛数随熊 誓逸資毅:

UNITED STATES, Bio-Rad Laboratories Inc.


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© 2023 Bio-Rad Laboratories Inc. Printed in the USA


Lyphochek鎌 宕拙 稲Ъ裳私 Bio-Rad Laboratories, Inc.裾 嗣頓性寒寛. 峠瀬創 2 祢稲焦/Korean • 2023-07 • 4037-00
Lyphochek Diabetes Control, Levels 1 and 2

방법 (1)
레벨 1 - 85871 레벨 2 - 85872
단위 (2) 평균 범위 평균 범위
HEMOGLOBIN A1C
Abbott ARCHITECT cSystems (4P52 Enzymatic) % 4.82 4.16 – 5.48 9.73 8.93 – 10.5
ARKRAY ADAMS A1C HA-8160 (Ver. 4.xx)/ HA-8170/
HA-8180/ HA-8180T/ HA-8181/ HA-8190V/ HYBRID
AH-8280/ AH-8290/ Lite HA-8380/ HA-8380V/
HA-8180V (3) %
ARKRAY ADAMS A1C HA-8180V (3) % 5.00 4.50 – 5.50 9.80 8.90 – 10.7
Beckman Coulter AU Systems (REF B00389) % 5.08 4.28 – 5.89 9.63 7.93 – 11.3
Beckman Coulter UniCel DxC Series % 5.45 4.58 – 6.32 10.7 8.85 – 12.4
Bio-Rad D-10 A1c Dual Program 220-0201 (4) % 5.19 4.62 – 5.76 10.5 9.02 – 12.0
Bio-Rad D-10 Dual A2/F/A1c Program 220-0201 (4) % 5.27 4.68 – 5.86 10.2 8.71 – 11.7
Bio-Rad D-10 Hemoglobin A1c 220-0101 / 12000949
(4) % 5.09 4.54 – 5.64 10.3 8.83 – 11.8
Bio-Rad D-100 HbA1c (4) % 5.18 4.61 – 5.76 10.2 8.76 – 11.7
Bio-Rad VARIANT II Dual Kit Beta-Thal 270-2500 (5) % 4.88 4.36 – 5.39 10.1 8.60 – 11.6
Bio-Rad VARIANT II HbA1c Dual Program 270-2500
(5) % 5.00 4.46 – 5.54 10.1 8.63 – 11.6
Bio-Rad VARIANT II Hemoglobin A1c Program
270-2101NU (4) % 5.28 4.68 – 5.87 10.4 8.88 – 11.9
Bio-Rad VARIANT II TURBO HbA1c 2.0 12000447 (4) % 5.04 4.49 – 5.58 10.0 8.53 – 11.5
Bio-Rad VARIANT II TURBO HbA1c 2.0 270-2455EX
(4) % 5.04 4.49 – 5.58 10.0 8.53 – 11.5
Boditech AFIAS Series (3) %
Boditech iCHROMA Series (3) %
Diazyme Direct Enzymatic HbA1c DZ168C (Roche
Hitachi Systems, International / Modular) (3) % 5.90 4.70 – 7.10 9.70 7.80 – 11.6
EKF (Quotient) Diagnostics Quo-Lab (3) % 5.50 4.90 – 6.00 10.3 9.30 – 11.3
EKF (Quotient) Diagnostics Quo-Test (3) % 5.50 4.90 – 6.00 10.1 9.00 – 11.1
HemoCue HbA1c 501 (3) % 5.10 4.09 – 6.11 10.0 8.01 – 12.0
Infopia / Osang Healthcare Clover A1c (3) % 4.90 <4.00 – 5.88 9.60 7.69 – 11.5
Infopia / Osang Healthcare Clover A1c Plus (3) % 5.10 4.09 – 6.11 10.0 8.01 – 12.0
Infopia / Osang Healthcare Clover A1c Self (3) % 5.00 4.01 – 6.00 9.70 7.77 – 11.6
JEOL BM Test HbA1c (3) % 4.69 3.75 – 5.63 9.67 7.74 – 11.6
Ortho VITROS Microtip Series (HBA1C REF 6842905) % 4.92 4.14 – 5.69 9.80 7.98 – 11.6
Pointe Scientific Inc. Hemoglobin A1c H7546
(Beckman Coulter AU Systems) (3) %
Precision Biosensor Exdia PT10 (3) % § §
PTS Diagnostics A1CNOW+ (3) % 5.03 4.02 – 6.03 9.61 7.68 – 11.5
Roche cobas c System (Tina-quant hbA1c Gen2/Gen3) % 4.98 4.33 – 5.63 9.70 8.35 – 11.0
Roche cobas INTEGRA (Tina-quant Hemoglobin A1c) % 5.25 4.54 – 5.96 10.1 8.60 – 11.7
SAKAE A1c Gear (3) % 5.30 4.30 – 6.40 10.6 8.50 – >12.5
SAKAE A1c iGEAR (3) % 5.30 4.30 – 6.40 10.8 8.60 – >12.5
SAKAE A1c iGEAR QUICK (3) % 5.30 4.30 – 6.40 10.5 8.40 – 12.6
SEBIA CAPI 3 Hb A1c (Cat. 2515) / CAPI 3
INSTRUMENT (3) % 4.90 4.30 – 5.50 10.3 9.30 – 11.3
SEBIA CAPILLARYS hb A1c (Cat. 2015) / CAPPILARYS
2 FLEX PIERCING INSTRUMENT (3) %
SEBIA MINICAP Hb A1c (Cat. 2215) / MINICAP FLEX
PIERCING INSTRUMENT (3) %
SEKISUI (RE) NORUDIA N HbA1c (3) % 4.74 3.79 – 5.69 9.67 7.74 – 11.6
SEKISUI NORUDIA N HbA1c (3) % 4.79 3.83 – 5.75 9.61 7.69 – 11.5
Siemens ADVIA Chemistry Systems (Enzymatic
Hemoglobin A1c, A1c_E / A1c_EM) % 4.67 3.94 – 5.41 9.76 8.04 – 11.5

페이지 3 한국어/Korean • 2023-07 • 4037-00

8
Lyphochek Diabetes Control, Levels 1 and 2

방법 (1)
레벨 1 - 85871 레벨 2 - 85872
단위 (2) 평균 범위 평균 범위
HEMOGLOBIN A1C (지속)
Siemens Atellica Solution Enzymatic Hemoglobin A1c
(A1c_E / A1c_H) % 4.76 4.03 – 5.50 9.69 7.99 – 11.4
Siemens DCA Series % 5.35 4.63 – 6.07 10.2 8.94 – 11.4
Siemens Dimension Series (A1C REF DF105B) % 5.01 4.44 – 5.58 9.84 8.96 – 10.7
Siemens Dimension Vista Systems A1C REF K3105B % 5.10 4.54 – 5.66 10.0 8.56 – 11.5
TOSOH G11 Automated HPLC Analyzer (3) % 5.10 4.60 – 5.60 10.0 9.00 – 11.0
Tosoh G8 Automated HPLC Analyzer (3) % 5.10 4.60 – 5.60 10.0 9.00 – 11.0
TOSOH GX Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 10.1 9.10 – 11.1
TOSOH HLC-723 G8,G9,G11 (3) % 5.20 4.68 – 5.72 9.91 8.92 – 10.9
Trinity Biotech Premier Hb9210 (3) %

페이지 4 한국어/Korean • 2023-07 • 4037-00

8
Lyphochek Diabetes Control, Levels 1 and 2

기구 (1)
레벨 1 - 85871 레벨 2 - 85872
단위 (2) 평균 범위 평균 범위
Ortho VITROS MicroTip Series
Hemoglobin A1C (HBA1C REF 6842905) % 4.92 4.14 – 5.69 9.80 7.98 – 11.6
Hemoglobin A1C (HBA1C REF 6842905) (Mass/Volume) g/dL 0.477 0.331 – 0.622 1.00 0.733 – 1.27
Hemoglobin, Total (HBA1C REF 6842905) g/dL 15.6 11.4 – 19.9 11.9 8.96 – 14.9
Roche cobas c Systems
Hemoglobin A1C (Tina-quant hbA1c Gen2/Gen3) % 4.98 4.33 – 5.63 9.70 8.35 – 11.0
Hemoglobin A1C (Tina-quant hbA1c Gen2/Gen3)
(Mass/Volume) g/dL 0.525 0.371 – 0.680 1.08 0.801 – 1.35
Hemoglobin, Total (Tina-quant hbA1c Gen2/Gen3) g/dL 16.9 12.0 – 21.9 12.9 8.90 – 16.9
Roche cobas INTEGRA
Hemoglobin A1C (Tina-quant Hemoglobin A1c) % 5.25 4.54 – 5.96 10.1 8.60 – 11.7
Hemoglobin A1C (Tina-quant Hemoglobin A1c)
(Mass/Volume) g/dL 0.496 0.344 – 0.649 0.988 0.736 – 1.24
Hemoglobin, Total (Tina-quant Hemoglobin A1c) g/dL 14.5 10.9 – 18.0 11.2 8.02 – 14.4
Siemens ADVIA Chemistry Systems
Hemoglobin A1C (Enzymatic Hemoglobin A1c, A1c_E /
A1c_EM) % 4.67 3.94 – 5.41 9.76 8.04 – 11.5
Hemoglobin A1C (Enzymatic Hemoglobin A1c, A1c_E /
A1c_EM) (Molarity/Volume) μmol/L 4.53 <2.97 – 6.43 10.8 8.32 – 13.4
Hemoglobin, Total (tHb_E / tHb_EM) g/dL 15.1 11.4 – 18.9 12.0 9.33 – 14.7

각주
(1) 모든 각주가 귀하의 맞춤 선택 데이터 차트에 적용되지 않을 수도 있습니다.
(2) NGSP 단위 = %, IFCC 단위 = mmol/mol
(3) 기재된 수치값은 시약 및/또는 기구 제조업체의 프로토콜을 사용하여 결정되었으며 ±3SD 범위를 나타내지 않을 수 있습니다.
(4) 설정값은 1:300의 비율로 희석하여 얻은 값입니다(라벨이 표시된 1.5mL 유리병에 Wash/Diluent Solution을 1.5mL만큼 피펫으로 넣은
후 용해된 컨트롤을 5μL넣습니다. 컨트롤을 넣은 각 유리병의 뚜껑을 닫은 후 골고루 섞이도록 흔듭니다).
(5) 설정값은 1:200의 비율로 희석하여 얻은 값입니다(라벨이 표시된 1.5mL 유리병에 Wash/Diluent Solution을 1.0mL만큼 피펫으로 넣은
후 컨트롤을 5μL를 넣습니다. 컨트롤을 넣은 각 유리병의 뚜껑을 닫은 후 골고루 섞이도록 흔듭니다).
현재 데이터를 이용할 수 없습니다. 문의해 주십시오.
§ 이 분석을 위한 평균 및 허용 범위를 설정하기 위해 필요한 데이터는 제한된 할당 참여로 인해 얻어지지 않았습니다. 만약 귀하의
기관이 이 분석을 위한 측정치 할당 프로그램에 참여하는 것에 관심이 있으시면, 귀하의 현지 Bio-Rad 사무소에 연락하십시오.

Lyphochek는 특정 국가에서 Bio-Rad Laboratories, Inc.의 상표입니다. 페이지 5 한국어/Korean • 2023-07 • 4037-00

Lyphochek Diabetes Control
Levels 1 and 2
740
740X
Bilevel
MiniPak
6 x 0.5 mL
2 x 0.5 mL
85870
Level 1
85871
Level 2
85872
20
Lyphochek Diabetes Control, Levels 1 and 2
峠瀬創 2
 • 2023-07 • 4037-00
/Korean
祢稲焦
懇糸悟蟻
Hemoglobin
Hemoglobin (Total Glycated)
Lyphochek Diabetes Control, Levels 1 and 2
페이지 3
 • 2023-07 • 4037-00
/Korean
한국어
방법 (1)
레벨 1 - 85871
레벨 2 - 85872
단위 (2)
평균
Lyphochek Diabetes Control, Levels 1 and 2
페이지 4
 • 2023-07 • 4037-00
/Korean
한국어
방법 (1)
레벨 1 - 85871
레벨 2 - 85872
단위 (2)
평균
Lyphochek Diabetes Control, Levels 1 and 2
페이지 5
 • 2023-07 • 4037-00
/Korean
한국어
기구 (1)
레벨 1 - 85871
레벨 2 - 85872
단위 (2)
평균

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