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China

AmoyDx Medical Institute

Room 601, Chengye Building, Pioneer Park, No. 11 Huoju East Road, Huli District, Xiamen, 361009, People's Republic of China, Xiamen, China

A2LA|6588.01ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
2
Standards
0
Locations
1

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Register record

A2LARefreshed
6588.01Active

Accredited standards

We found no published test standard numbers in this lab’s scope (labs often list in-house methods instead). The full scope as published is below.

Scope as published by A2LA

2 lines
A2LA

ISO/IEC 17025

Active

6588.01

The scope document we hold says it is valid until 2028-03-31.

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Accredited scope, certificate 6588.01

This scope has not been split into individual lines yet. Below is the text of the scope document as published.

Part 1 of 2

(A2LA Cert. No. 6588.01) 01/27/2026 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO 15189:2022 AMOYDX MEDICAL INSTITUTE Room 601, Chengye Building, Pioneer Park, No. 11 Huoju East Road, Huli District Fujian, Xiamen, PEOPLE’S REPUBLIC OF CHINA 361009 Dr. Hui Jin Phone: +86-13606923436 CLINICAL Valid To: March 31, 2028 Certificate Number: 6588.01 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 Whole Blood (WB) and Formalin Fixed Paraffin Embedded (FFPE) Tissues: Specialty Sub Specialty Test/Analyte Method Matrix(ces) Pathology Molecular Pathology BRAF PCR FFPE BRCA1/2 Next Generation Sequencing WB, FFPE C-kit Sanger Sequencing FFPE EGFR PCR FFPE HER2 FISH FFPE KRAS PCR FFPE LC10(EGFR/ALK/ROS 1/RET/KRAS/NRAS/PI K3CA/BRAF/ HER2/MET) Next Generation Sequencing WB, FFPE LMG(EGFR/ALK/ROS 1/KRAS/BRAF) PCR FFPE MSI Sanger Sequencing FFPE NRAS PCR FFPE PDGFRA Sanger Sequencing FFPE PD-L1 IHC FFPE

Part 2 of 2

For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation. Accredited Laboratory A2LA has accredited AMOYDX MEDICAL INSTITUTE Xiamen, 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 27th day of January 2026. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 6588.01 Valid to March 31, 2028

Text extracted from the accredited scope document. Layout and tables from the original may not carry over; the scope document itself is the authoritative copy.

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