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China

MyGene Diagnostics Co.,Ltd

Unit A501 Guangzhou lntl Biotech lsland No 9 The 4th Luoxuan Rd Guangzhou, Guangdong, Guangzhou, People's Republic of China, Guangzhou, China

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A2LA 7283.01ISO/IEC 17025Register refreshed 2026-11-06

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A2LA accredited scope

What this lab is accredited for

We found no published test standard numbers in this lab’s scope. The full scope as published is below.

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A2LA certificate 7283.01 · 2 lines

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1-Tissue
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 7283.01) Revised 05/13/2025 Page 1 of 1 SCOPE OF ACCREDIATION TO ISO 15189:2022 MYGENE DIAGNOSTICS CO., LTD LABORATORY Unit A501 Guangzhou lntl Biotech lsland No 9 The 4th Luoxuan Rd Guangzhou, Guangdong, People’s Republic of China Zhe Huang Phone Number: +86 13277079550 CLINICAL Valid to: June 30, 2026 Certificate Number: 7283.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including Tissue: Specialty Sub Specialty Test/Analyte Method Matrix Pathology Molecular Pathology Colorectal Ca ncer 10- Gene Test NGS Tissue
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Extracted from the scope document; tables may not line up. View scope for the original.

For the tests to which this accreditation applies, please refer to the laboratory’s «field» Scope of Accreditation. Accredited Laboratory A2LA has accredited MYGENE DIAGNOSTICS CO., LTD LABORATORY Guangzhou, People’s Republic of China for technical competence in the field of Clinical This laboratory is accredited in accordance with the recognized International Standard ISO 15189:2022 Medical laboratories - Requirements for quality and competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint IAF-ILAC-ISO Communiqué dated November 2021). Presented this 8th day of May 2024. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 7283.01 Valid to June 30, 2026

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

Unit A501 Guangzhou lntl Biotech lsland No 9 The 4th Luoxuan Rd Guangzhou, Guangdong, Guangzhou, People's Republic of China, Guangzhou, CN

23.11981, 113.31478

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Accreditation data refreshed from the A2LA register on .

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