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U.S. Department of Health and Human Services

ASCA-Accredited Testing Laboratories
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This page lists ASCA-accredited testing laboratories and their respective scopes of accreditation.

Notes:

  • Testing laboratories who wish to participate in ASCA should demonstrate that they have been accredited by an ASCA-recognized accreditation body to the currently FDA-recognized versions of the standards and test methods included in ASCA. Please check the Recognized Consensus Standards database for the currently recognized versions.
  • Some FDA-recognized consensus standards included in ASCA have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). If a testing laboratory has an international (e.g., IEC, ISO) version of a standard in their scope of ASCA Accreditation, any identical US adoption associated with the FDA Recognition number is also considered included in the testing laboratory's scope. For example, if IEC 60601-2-47 with FDA Recognition number 3-155 is listed in a testing laboratory's scope of ASCA Accreditation, testing to the associated ANSI AAMI IEC version is also acceptable even if it is not explicitly listed in the testing lab's scope.
  • Some FDA-recognized international consensus standards (e.g., IEC, ISO) included in ASCA are recognized specifically with U.S. national differences applied (e.g., IEC 60601-1, IEC 61010-1). When U.S. national differences are applied to the international versions, they are considered equivalent to the corresponding U.S. adoptions of those standards (e.g., ANSI AAMI ES60601-1, ANSI UL 61010-1). For testing laboratories listed below with such standards in their scope, both the US adoptions and the international versions of the standards are considered as part of their scope of ASCA Accreditation.
  • For a list of testing laboratories with Withdrawn ASCA Accreditation, see here

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    Test Lab: WuXi Apptec Suzhou [TL-83]
    Accreditation Status: Accreditation Granted - Start Date: 05/10/2023
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Jiyi Duan, ASCA@wuxiapptec.com, No. 818 Songjia Road, Guoxiang Street Wuzhong District Suzhou, Jiangsu CN 215124
     
    Scope of ASCA Accreditation
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    		Return to list of Testing Labs
    Status
    Status
    Date
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    Category
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    Biocompatibility
    Test
    Method
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    Recognition
    Number
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    Standards
    Development
    Organization
    Standard Designation
    Number and Date
    Title
    Exclusions
    Accreditation Granted 11/20/2024 Biocompatibility Complement Activation using a U.S. marketed ELISA kit 2-248 ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
    Accreditation Granted 06/14/2023 Biocompatibility Direct and Indirect Hemolysis 2-248

    2-250     		ISO

    ASTM     		10993-4 Third edition 2017-04

    F756-17     		Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
    Standard Practice for Assessment of Hemolytic Properties of Materials
    Accreditation Granted 05/10/2023 Biocompatibility Sample preparation for all test types 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
    Accreditation Granted 05/10/2023 Biocompatibility MEM Elution Cytotoxicity 2-245 ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
     
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    Action Type
    ASCA Status
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    Biocompatibility
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    Recognition
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    Exclusions
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