cholesterol reference method laboratory network …

CHOLESTEROL REFERENCE METHOD

LABORATORY NETWORK (CRMLN)

LIST OF ANALYTICAL SYSTEMS & REAGENTS

CERTIFIED FOR TOTAL CHOLESTEROL (TC)

Date Updated: July 2018

The Cholesterol Reference Method Laboratory Network (CRMLN) has certified the

following systems as having documented traceability to the CDC Lipids Reference

Laboratory for total cholesterol. Detailed description about the analytical system

evaluated, including instrument, calibrator, and reagent information, along with

contact information for each laboratory is listed in the following section.

Certificates for clinical laboratories expire two years after the date the evaluation

is performed.

Abaxis, Inc.

Dennis M. Bleile

Abaxis, Inc.

3240 Whipple Road, Union City, CA 94587

Phone: (510) 675-6515

Instrument Reagent Reagent Lot(s) Calibrator

Calibrator

Lot(s) Matrix

Certification

Date

Network

Laboratory Test Site

Piccolo Xpress®

Chemistry

Analyzer

Piccolo®Total

Cholesterol

Test

6211AB2 Abaxis Internal

Cal Set

I656/2494/I685

/I699

Serum 08/30/2016 CEQAL,Inc. Waltham, MA,

USA

Abbott Laboratories

Dror Yahalom, PhD

Abbott Laboratories

1921 Hurd Drive, Irving, Texas 75038

Phone: 972-518-6716


Calibrator

Lot(s) Matrix

Certification

Date

Network


Architect

cSystems c400

Total

Cholesterol

03214UN16 MCC 78377FD01 Venus Serum 2/24/2017 CEQAL, Inc. Irving, TX, USA

Architect

cSystems c800

Total

Cholesterol

03214UN16 MCC 78377FD01 Venus Serum 2/24/2017 CEQAL,Inc. Irving, TX, USA

Architect

cSystems

c1600

Total

Cholesterol

03214UN16 MCC 78377FD01 Venus Serum 2/24/2017 CEQAL,Inc. Irving, TX, USA

ACON laboratories, Inc.

Bingchen Liu

ACON laboratories, Inc.

10125 Mesa Rim Road, San Diego, CA92121, USA

Phone: 875-8021


Calibrator

Lot(s) Matrix

Certification

Date

Network


Mission Ultra

Cholesterol

Monitoring

System

CHOL Total

Cholesterol

Test Strips

CH160812D-1 NA 201606076 Whole blood 3/20/2017 Beijing

Institute of

Geriatrics

San Diego, CA,

USA

Mission

Cholesterol

Monitoring

System

Mission

Cholesterol

Test Device

OCH6080001 NA 160803 Plasma 3/20/2017 Beijing

Institute of

Geriatrics

San Diego, CA,

USA

Mission

Cholesterol

Monitoring

System

Mission

Cholesterol

Test Device

OCH6080001 NA 160803 Venous serum 3/20/2017 Beijing

Institute of

Geriatrics

San Diego, CA,

USA

Mission

Cholesterol

Monitoring

System

Mission

Cholesterol

Test Device

OCH6080001 NA 160803 Whole blood 3/20/2017 Beijing

Institute of

Geriatrics

San Diego, CA,

USA

Alere San Diego Inc.

Josh Goen

Alere San Diego Inc.

9975 Summers Ridge Rd, C-1031, San Diego, CA 92121

Phone: (858) 805-2194

Instrument Reagent Reagent Lot(s) Calibrator Calibrator Lot(s) Matrix

Certification

Date

Network


Alere Alere 408157A Alere C3312L1 Venous Serum 7/31/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

San Diego, CA,

USA

Alere Alere 408156 Alere C3312L1 Serum 7/31/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

San Diego, CA,

USA

Alere Alere 408159A Alere C3312L1 Venous Serum 7/31/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

San Diego, CA,

USA

Alere Technologies AS

Josh Goen

Alere Technologies AS

9975 Summers Ridge Rd, C-1031, San Diego, CA 92121

Phone: (858) 805-2194


Calibrator

Lot(s) Matrix

Certification

Date

Network


Alere Afinion AS

100 analyzer

AS0015133

Alere Afinion

Lipid Panel

10182169 -- -- Serum 8/12/2016 Erasmus MC Waltham, MA,

USA

Alere Afinion AS

100 analyzer

AS0026284

Alere Afinion

Lipid Panel

10182169 -- -- Serum 8/12/2016 Erasmus MC Waltham, MA,

USA

B.M.L., Kawagoe Laboratory

Nobuki Arai

B.M.L., Kawagoe Laboratory

1361-1 Matoba, Kawagoe, Saitama, Japan 350-1101

Phone: 049-232-0409


Calibrator

Lot(s) Matrix

Certification

Date

Network


JCA-BM2250 L-type CHO・

M

R1: DJ863 Multi

Calibrator

Lipids

DM040 Venous Serum 5/19/2017 National

Cerebral and

Cardiovascular

Center

,

BCI-Value Assignment Dept

Marcia Mikolajczak

BCI-Value Assignment Dept

2470 Faraday Ave. Carlsbad, CA 92010

Phone: (800)-877-8128


Calibrator

Lot(s) Matrix

Certification

Date

Network


Beckman

Coulter® Inc.

SYNCHRON®

SYSTEMS

CHOLESTEROL

M710188 SYNCHRON®

Multicalibrator

M610080 Venous Serum 11/14/2017 CEQAL, Inc. Carlsbad, CA,

United States

Beckman

Coulter® Inc.

SYNCHRON®

SYSTEMS

CHOLESTEROL

M704105 SYNCHRON®

Multicalibrator

M610080 Venous Serum 11/14/2017 CEQAL, Inc. Carlsbad, CA,

United States

Beckman Coulter

Liam Malone

Beckman Coulter

Lismeehan, Co. Clare, Ireland

Phone: 065 6831439

Instrument Reagent Reagent Lot(s) Calibrator Calibrator Lot(s) Matrix Certification Date Network Laboratory Test Site

AU480 OSR6x16 2107 DR0070 6102K61 Serum 10/10/2017 Erasmus MC Co. Clare,

AU680 OSR6x16 2107 66300 119M Serum 10/10/2017 Erasmus MC Co. Clare,

AU680 OSR6x16 2107 66300 120S Serum 10/10/2017 Erasmus MC Co. Clare,

AU5800 OSR6x16 2107 66300 119M Serum 10/10/2017 Erasmus MC Co. Clare,

AU5800 OSR6x16 2107 66300 120S Serum 10/10/2017 Erasmus MC Co. Clare,

AU5800 OSR6x16 2107 DR0070 6102K61 Serum 10/10/2017 Erasmus MC Co. Clare,

DxC700AU OSR6x16 2107 66300 119M Serum 10/10/2017 Erasmus MC Co. Clare,

DxC700AU OSR6x16 2107 DR0070 6102K61 Serum 10/10/2017 Erasmus MC Co. Clare,

Beckman Coulter®, Inc.

Liam Malone

Beckman Coulter®, Inc.

Lismeehan, Co. Clare, Ireland

Phone: 065 6831439


Calibrator

Lot(s) Matrix

Certification

Date

Network


Synchron DXC Synchron

Systems

Cholesterol

Reagent

M507501 Synchron®

Multicalibrator

M410084 Venous Serum 1/27/2016 CEQAL Inc. Carlsbad, CA,

USA

BEIJING WANTAI DRD CO., LTD

Ruijie Wang

BEIJING WANTAI DRD CO., LTD

31 Science Park Road, Changping District, Beijing

Phone: +86 13693570786


Calibrator

Lot(s) Matrix

Certification

Date

Network


HITACHI CHOLESTEROL 7103A RANDOX

LABORATORIES

LTD

915UE Serum 5/10/2018 Beijing Institute

of Geriatrics

Changping

District,

DENKA SEIKEN Co., Ltd., KAGAMIDA FACTORY

Takumi Gawasawa

DENKA SEIKEN Co., Ltd., KAGAMIDA FACTORY

1359-1 Kagamida Kigoshi, Gosen, Niigata, Japan 959-1695

Phone: 0250-42-7137


Calibrator

Lot(s) Matrix

Certification

Date

Network


JEOL BM6050 T-CHO(S)N

SEIKEN

R1: 737021 Lipid-

Calibrator-D

806031 Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Niigata,

Hitachi 7180 T-CHO(S)N

SEIKEN

R1: 737021 Lipid-

Calibrator-D


Cerebral and

Cardiovascular

Center

Niigata,

TOSHIBA TBA-

2000FR

T-CHO(S)N

SEIKEN

R1: 737021 Lipid-

Calibrator-D


Cerebral and

Cardiovascular

Center

Niigata,

ELITech Clinical Systems

Edwige GUAIS

ELITech Clinical Systems

Zone Industrielle, 61500 Sées France

Phone: +33(0)2 14 43 10 03


Calibrator

Lot(s) Matrix

Certification

Date

Network


ENVOY 500 CHOLESTEROL

ENVOY

A150756 ELICAL 2 R151494 -- 8/24/2016 Erasmus MC Waltham, MA,

USA

Selectra ProM CHOLESTEROL

SL

A150756 ELICAL 2 R151494 -- 8/24/2016 Erasmus MC Waltham, MA,

USA

Kyowa Medex Co., Ltd., Fuji Plant

Nobuyuki Sueshige

Kyowa Medex Co., Ltd., Fuji Plant

600-1 Minami-Ishiki Nagaizumi-cho, Sunto-gun, Shizuoka, Japan 411-0932

Phone: 055-988-6035


Calibrator

Lot(s) Matrix

Certification

Date

Network


Hitachi 7180B Determiner C

TC

R1: 291AFL Determiner

Standard

Serum

168AFL Venous Serum 5/15/2017 National

Cerebral and

Cardiovascular

Center

Shizuoka,

Hitachi 7180B Determiner L

TC II

R1: 258AFK Determiner

Standard

Serum

168AFL Venous Serum 5/15/2017 National

Cerebral and

Cardiovascular

Center

Shizuoka,

Medica Corporation

Sheldon S. Cantor

Medica Corporation

5 Oak Park Drive, Bedford, MA 01730

Phone: ( 781) 541-7408


Calibrator

Lot(s) Matrix

Certification

Date

Network


Medica

Corporation

Total

Cholesterol

17284 EasyRA

Chemistry CAL

14353 Serum 12/13/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Bedford, MA,

USA

Ortho Clinical Diagnostics

Michael Castro

Ortho Clinical Diagnostics

100 Indigo Creek Drive, B313, Rochester, NY 14626

Phone: (585) 453-5585


Calibrator

Lot(s) Matrix

Certification

Date

Network


Cobas® c111 VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2

Kit 267 SERUM 4/11/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cobas® c501 VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2

Kit 267 serum 4/11/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cobas® c701 VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2

Kit 267 Serum 4/11/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cobas Integra

400/400 plus

VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2


Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cobas Integra

800

VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2


Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

MODULAR

ANALYTICS D

Module

VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2


Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

MODULAR

ANALYTICS P

Module

VITROS

Chemistry

Products CHOL

Slides

Gen 39; Lot

3348-6623

VITROS

Calibrator Kit 2


Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cardio Chek®

PA®

0 0 0 0 Whole Blood 7/31/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

Cardio Chek®

Plus®


Metabolism &

Diabetes

Research Labs.

Indianapolis,

IN, USA

OSANG Healthcare Co., Ltd.

Hyeonah Jeong

OSANG Healthcare Co., Ltd.

132 Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040, Korea

Phone: 82-31-460-0461


Calibrator

Lot(s) Matrix

Certification

Date

Network


ElementTM

Multi

ElementTM

Multi Total

Cholesterol

Test Strip

0 0 0 Plasma(EDTA) 8/9/2017 Beijing

Institute of

Geriatrics

Gyeonggi-do,

ElementTM

Multi

ElementTM

Multi Total

Cholesterol

Test Strip

0 0 0 Whole Blood 8/9/2017 Beijing

Institute of

Geriatrics

Gyeonggi-do,

LandmarkTM ElementTM

Multi Total

Cholesterol

Test Strip


Institute of

Geriatrics

Gyeonggi-do,

LipidPlusTM ElementTM

Multi Total

Cholesterol

Test Strip


Institute of

Geriatrics

Gyeonggi-do,

LandmarkTM ElementTM

Multi Total

Cholesterol

Test Strip


Institute of

Geriatrics

Gyeonggi-do,

LipidPlusTM ElementTM

Multi Total

Cholesterol

Test Strip


Institute of

Geriatrics

Gyeonggi-do,

LipidProTM ElementTM

Multi Total

Cholesterol

Test Strip


Institute of

Geriatrics

Gyeonggi-do,

LipidProTM ElementTM

Multi Total

Cholesterol

Test Strip

0 0 0 Whole blood 8/9/2017 Beijing

Institute of

Geriatrics

Gyeonggi-do,

Polymer Technology Systems Diagnostics

Michelle Evans

Polymer Technology Systems Diagnostics

7736 Zionsville Road, Indianapolis, IN 46268

Phone: (317) 870-5610 Ext. 1102


Calibrator

Lot(s) Matrix

Certification

Date

Network


Cardio Chek®

PA®


Metabolism &

Diabetes

Research Labs.

Indianapolis, IN,

USA

Cardio Chek®

Plus®


Metabolism &

Diabetes

Research Labs.

Indianapolis, IN,

USA

Roche Diagnostics

Cristina Canada-Vilalta, PhD.

Roche Diagnostics

9115 Hague Road, Indianapolis, IN 46250-0416

Phone: (317) 521-7691


Certification

Date

Network


Cobas® c311 Roche

Cholesterol

CHOD-PAP

14241101 C.f.a.s 186488 Serum 4/11/2017 NW Lipid

Metabolism &

Diabetes

Research Labs.

Indianapolis, IN,

USA

SD biosensor

SunYoung Jeong

SD biosensor

C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Phone: 31-300-0423


Certification

Date

Network


SD LipidoCare LipidoCare Profile

strip

LS1016008 -- -- Serum 3/22/2017 Beijing Institute

of Geriatrics

,

Sekisui Diagnostics P.E.I. Inc.

Cindy Tait

Sekisui Diagnostics P.E.I. Inc.

70 Watts Avenue, Charlottetown, PE C1E 2B9

Phone: 902-628-0927


Calibrator

Lot(s) Matrix

Certification

Date

Network


Tokyo Boeki

Medisys Inc.

Sekisui

Diagnostics

51571 DC-Cal 51054 serum 12/18/2017 CEQAL,Inc. Charlottetown,

PE, Canada

SEKISUI MEDICAL Co., Ltd., Tsukuba Plant

Yoshinori Motoyama

SEKISUI MEDICAL Co., Ltd., Tsukuba Plant

3-1 Koyodai 3-chome, Ryugasaki, Ibaraki, Japan 301-0852

Phone: 0297-62-7551


Calibrator

Lot(s) Matrix

Certification

Date

Network


Hitachi 7180 Cholestest CHO R1: 101RBO Cholestest N

Calibrator

101RBO Venous Serum 5/17/2017 National

Cerebral and

Cardiovascular

Center

Ibaraki,

Hitachi 7170 Pureauto S

CHO-N

R1: 102RCO Cholestest N

Calibrator


Cerebral and

Cardiovascular

Center

Ibaraki,

Hitachi 7170 Cholestest CHO R1: 101RBO Cholestest N

Calibrator


Cerebral and

Cardiovascular

Center

Ibaraki,

Hitachi 7180 Pureauto S

CHO-N

R1: 102RCO Cholestest N

Calibrator


Cerebral and

Cardiovascular

Center

Ibaraki,

Sichuan Xincheng Biological Co., LTD

Hong Chen

Sichuan Xincheng Biological Co., LTD

No.101,Tianxin Road,Hi-tech Industrial Development Zone,Chengdu

Phone: (86028) 87822789


Calibrator

Lot(s) Matrix

Certification

Date

Network


Toshiba

TBA120FR

Cholesterol

(CHOD-PAP)

’0516031 Xincheng Chol

Cal

’0516031 Serum 8/12/2016 Beijing Institute

of Geriatrics

Waltham, MA,

USA

XC8001 Cholesterol

(CHOD-PAP)


Cal


of Geriatrics

Waltham, MA,

USA

Hitachi 7180 Cholesterol

(CHOD-PAP)


Cal


of Geriatrics

Waltham, MA,

USA

Beckman

Coulter AU 680

Cholesterol

(CHOD-PAP)


Cal


of Geriatrics

Waltham, MA,

USA

Siemens Healthcare Diagnostics

Justin Thomas

Siemens Healthcare Diagnostics

100 GBC Drive / B100 Newark, DE 19714

Phone: 302-631-6735


Calibrator

Lot(s) Matrix

Certification

Date

Network


Atellica™ CH

Analyzer

Chol_2 260201 Chemistry

Calibrator

680726B Serum 3/14/2017 CEQAL, Inc. Newark, DE,

USA

Dimension

Vista®

Dimension

Vista® CHOL

Flex® Reagent

16209AC Vista CHEM 1

calibrator

6DM081 SERUM 11/8/2016 NW Lipid

Metabolism &

Diabetes

Research Labs.

Newark, DE,

USA

Dimension®

XPAND

Dimension®

CHOL Flex®

Reagent

Cartridge

BA7235 Dimension®

CHOL

Calibrator

5MD078 SERUM 11/8/2016 NW Lipid

Metabolism &

Diabetes

Research Labs.

Newark, DE,

USA

Dimension®

RxL

Dimension®

CHOL Flex®

Reagent

Cartridge

BA7235 Dimension®

CHOL

Calibrator


Metabolism &

Diabetes

Research Labs.

Newark, DE,

USA

Dimension® ExL Dimension®

CHOL Flex®

Reagent

Cartridge

BA7235 Dimension®

CHOL

Calibrator


Metabolism &

Diabetes

Research Labs.

Newark, DE,

USA

SRL, Inc.

HIROAKI TAKESUE

SRL, Inc.

1006-1 Komiya-cho, Hachioji, Tokyo, Japan 192-0031

Phone: 042-648-4360


Calibrator

Lot(s) Matrix

Certification

Date

Network


JCA-BM8060 Sysmex T-CHO

Reagent KL

R1: A078 Lipid Calibrator

neo

S6004 Venous Serum 5/16/2017 National

Cerebral and

Cardiovascular

Center

Tokyo,

SYSMEX INTERNATIONAL REAGENTS CO., LTD.

Akito Yaeo

SYSMEX INTERNATIONAL REAGENTS CO., LTD.

4-3-2 Takatsukadai, Nishi-ku, Kobe, Hyogo, Japan 651-2271

Phone: 078-991-2211


Calibrator

Lot(s) Matrix

Certification

Date

Network


Hitachi 7180 T-CHO Reagent

KL

R1: A079 Lipid Calibrator

neo

S6004 Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Hyogo,

TaiDoc Technology Corp.

Pei-Fen Yang

TaiDoc Technology Corp.

6F., No. 127, Wugong 2nd Road, 24888 Wugu Dist., New Taipei City 24888, Taiwan

Phone: 2-6625-8188 #6214


Calibrator

Lot(s) Matrix

Certification

Date

Network


Roche

Diagnostics

CHOL2 51571 CFAS 51054 Serum 1/30/2018 CEQAL, Inc. New Taipei

City, 0, Taiwan

TaiDoc

Technology

Corp.

Total

Cholesterol

Strip

51571 -- 51054 Whole blood 1/30/2018 CEQAL, Inc. New Taipei

City, 0, Taiwan

Cobas Integra

800

Total

Cholesterol

Strip

WC17J102 -- -- Serum 2/13/2018 CEQAL, Inc. Indianapolis,

IN, USA

MODULAR

ANALYTICS D

Module

Total

Cholesterol

Strip


IN, USA

MODULAR

ANALYTICS P

Module

Total

Cholesterol

Strip


IN, USA

Tosoh Corporation

Toshie Takoura

Tosoh Corporation

2743-1 Hayakawa, Ayase, Kanagawa, Japan 252-1123

Phone: 467-76-5384


Calibrator

Lot(s) Matrix

Certification

Date

Network


HLC®-729 LP2 [TOSOH]

Lipopropak

R1: LT-R102B Lipopropak®

Calibrator Set

LT-S03A Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Kanagawa,

UMA Co., Ltd.

Ikuko Miyamoto

UMA Co., Ltd.

2-19-6 Yokosuka, Matsudo, Chiba, Japan 270-0031

Phone: 047-710-4871


Calibrator

Lot(s) Matrix

Certification

Date

Network


7180 Measure TC R1: 155AFK Lipids Calibrator 114C Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Chiba,

Wako Pure Chemical Industries, Ltd., Diagnostics Research Laboratories

Shinji Matsugi

Wako Pure Chemical Industries, Ltd., Diagnostics Research Laboratories

6-1 Takada-cho, Amagasaki, Hyogo, Japan 661-0963

Phone: 06-6499-9133


Calibrator

Lot(s) Matrix

Certification

Date

Network


AU640 L-Type CHO M R1: DK588 Multi

Calibrator Lipid

DE952 Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Hyogo,

Hitachi 7170S L-Type CHO M R1: DK588 Multi

Calibrator Lipid

DE952 Venous Serum 5/12/2017 National

Cerebral and

Cardiovascular

Center

Hyogo,

ZHEJIANG ERKN BIOLOGICAL TECHNOLOGY CO.,LTD.

Wanyu Chi

ZHEJIANG ERKN BIOLOGICAL TECHNOLOGY CO.,LTD.

NO.1655，Binhai Road 1，Economic & Technological Development Zone, Wenzhou, Zhejiang

Phone: 13958809681


Calibrator

Lot(s) Matrix

Certification

Date

Network


BECKMANCOUL

TER

Total

Cholesterol

Determine

Reagent Kit

170903 TCH Calibrators 170903 serum 11/1/2017 Beijing Institute

of Geriatrics

Wenzhou,

Zhejiang

Province,

HITACHI Total

Cholesterol

Determine

Reagent Kit

170903 TCH Calibrators 170903 serum 11/1/2017 Beijing Institute

of Geriatrics

Wenzhou,

Zhejiang

Province,

cholesterol reference method laboratory network …

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