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American Screening Corporation
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    COMPLIANCE & REGULATORY DOCUMENTATION

    Certifications, licenses
    & FDA registrations.

    Find quality, licensing and regulatory documentation for your purchasing process.
    Need a specific certificate or product record? Our team can help.

    Request a document →

    Worldwide quality standards

    2 CREDENTIALS

    ISO 13485:2016 (Medical Devices QMS)

    Category
    Quality management
    Scope / region
    Design and manufacture of medical devices

    Quality management documentation for medical device manufacturing. Request a copy of the certificate, scope and applicable locations.

    Request documentation →

    MDSAP (Medical Device Single Audit Program)

    Category
    Audit program
    Scope / region
    Medical device quality management

    A single audit program covering participating regulatory authorities. Request the applicable audit or certification documentation.

    Request documentation →

    United States federal credentials

    2 CREDENTIALS

    CMS / CLIA

    Category
    Product documentation
    Scope / region
    CLIA-waived testing options

    Request documentation for a specific product’s CLIA categorization and intended use. Status varies by product; review the instructions for use.

    Request documentation →

    GSA Advantage

    Category
    Government purchasing
    Scope / region
    Federal procurement

    Ask our team for applicable federal purchasing information, vendor identifiers and contract details for your procurement needs.

    Request documentation →

    Louisiana state licenses

    3 CREDENTIALS

    Louisiana Board of Drug and Device Distributors

    Category
    State licensing
    Scope / region
    Louisiana

    Request licensing documentation for drug and medical device distribution in Louisiana.

    Request documentation →

    Louisiana Board of Pharmacy

    Category
    State licensing
    Scope / region
    Louisiana

    Request the applicable pharmacy licensing information and supporting documentation from our team.

    Request documentation →

    Louisiana Department of Revenue (Resale)

    Category
    Resale documentation
    Scope / region
    Louisiana

    Request resale and tax documentation for your vendor onboarding or purchasing requirements.

    Request documentation →

    International regulatory authorizations

    3 CREDENTIALS

    COFEPRIS (Mexico)

    Category
    Regulatory documentation
    Scope / region
    Mexico

    Request available Mexico regulatory documentation for the product or product category you are purchasing.

    Request documentation →

    Health Canada Authorization

    Category
    Regulatory documentation
    Scope / region
    Canada

    Request applicable Canadian licensing and product documentation. Include the SKU so our team can identify the relevant records.

    Request documentation →

    Saudi Food and Drug Authority (SFDA)

    Category
    Regulatory documentation
    Scope / region
    Saudi Arabia

    Request the applicable product authorization and supporting documents for your purchasing or compliance review.

    Request documentation →

    Need written verification of a credential?

    Tell us the document, product SKU and your procurement requirements.

    Request verification →

    DOCUMENT REQUEST

    Need a specific document?

    Request a certificate, product instructions, quality documentation, or other records for your compliance review. Include the product SKU and lot number where applicable.

    For assistance, call (866) 526-2873 or email compliance@americanscreeningcorp.com.

    Request a document

    Our team responds by email.

    Verifying ASC for a vendor onboarding form?

    Contact our team about purchasing records and supplier qualification documentation.

    ▥   Volume PricingSelect your order quantity

    Unit Price:

    Total:

    Quantities are individual tests, sold in full cases. Prices are per test.

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