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LNEHBA1C401

HbA1c in lyophilized hemolysates

LNE Certified Reference Material, commutable, JCTLM listed

form

liquid

quality

commutable, JCTLM listed

shelf life

limited shelf life, expiry date on the label

composition

lyophilized human blood hemolysates, 100%

IVD

not for in vitro diagnostic use

storage temp.

2-8°C

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General description

LNE CRM HbA1c 401 is a higher-order certified reference material produced by the French metrological institute LNE in compliance with ISO 17034 requirements. This Certified Reference Material LNE CRM HbA1c 401 corresponds to lyophilized human blood hemolysates and is intended for use as quality control materials for the verification of the accuracy of the reference method and routine methods used in clinical laboratories for the quantification of HbA1c in hemolysate or whole blood. Sample commutability was assessed through an extensive study involving seventeen of the most used method for the quantification of HbA1c in clinical laboratory using the difference in bias approach described in the IFCC recommendations on commutability assessment. Commutability results are reported in the certificate of analysis.

Storage Class Code

10 - Combustible liquids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

高风险级别生物产品--人源产品
动植物来源生物产品

Certificate of Analysis

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Certificate of Origin

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