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ISO13485 XQX014 XQX015 Rapid test kit

ISO13485 XQX014 XQX015 Rapid test kit

Product catalog summary
Certificate Overview:
This document certifies that Wuhan Xuqinxuan Biotechnology Co., Ltd. has been approved by LRQA Limited for its management system under the ISO 13485:2016 standard. The certificate is valid from 25 August 2022 to 24 August 2025.
Approval Details:
The approval number for ISO 13485 is 00037394. The scope of this approval includes the development, production, and sales of colloidal gold method and immunofluorescence in vitro diagnostic kits, specifically for export purposes. These kits are used for the auxiliary diagnosis of diseases and monitoring human physiological status.
Issuer Information:
The certificate was issued by LRQA Limited, located at 1 Trinity Park, Bickenhill Lane, Birmingham, United Kingdom. Rhett Wang, the Area Operations Manager for North Asia, is the signatory of the certificate.
Validity and Liability:
The certificate's validity can be verified on the CNCA website 30 working days post-issuance. LRQA assumes no liability for any loss or damage resulting from reliance on this document unless a contract exists with LRQA for the provision of this information.
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Catalog excerpts

ISO13485 XQX014 XQX015 Rapid test kit-1

Current issue date: Expiry date: Certificate identity number: Original approval(s): ISO 13485 - 25 August 2022 Certificate of Approval This is to certify that the Management System of: Wuhan Xuqinxuan Biotechnology Co., Ltd. Southwest of Floor A13, No. 666, Shendun 4th Road, Donghu New Technology Development Zone, Wuhan City, Hubei Province, China Unified Social Credit Code: 91420100MA49KB2H3P has been approved by LRQA to the following standards: The scope of this approval is applicable to: Development , Production and sales of Colloidal Gold method and Immunofluorescence in vitro diagnostic kits for auxiliary diagnosis of diseases and monitor human physiological status (Only for export). Rhett Wang ________________________ Area Operations Manager, North Asia Issued by: LRQA Limited The certificate can be checked for validity on CNCA website (www.cnca.gov.cn) 30 working days after the date of issuance. This approval is subject to surveillance assessment carried out in accordance with the LRQA assessment and certification procedures. LRQA Group Limited, its affiliates and subsidiaries and their respective officers, employees or agents are, individually and collectively, referred to in this clause as 'LRQA'. LRQA assumes no responsibility and shall not be liable to any person for any loss, damage or expense caused by reliance on the information or advice in this document or howsoever provided, unless that person has signed a contract with the relevant LRQA entity for the provision of this information or advice and in that case any responsibility or liability is exclusively on the terms and conditions set out in that contract. Issued by: LRQA Limited, 1 Trinity Park, Bickenhill Lane, Birmingham B37 7ES, United Kingdom Page 1 of 1

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