Compliance & Regulatory Documentation

Verified, current, and procurement-ready.

Every product we ship is supported by ISO-audited quality management and country-specific regulatory authorizations. Download verified PDFs below or request any document not displayed publicly.

Worldwide Quality Standards2 credentials

ISO 13485:2016 (Medical Devices QMS)

Active
Issued by
Intertek
Scope
Design & manufacture of IVDs
Last verified
2024

Quality management system for the design and manufacture of medical devices, audited and certified by Intertek under the international ISO 13485:2016 standard.

MDSAP (Medical Device Single Audit Program)

Active
Recognized in
US, CA, AU, BR, JP
Audit cycle
Annual

A single audit process satisfies the medical device regulatory requirements of five participating countries, demonstrating a globally harmonized QMS.

United States Federal Credentials2 credentials

CMS / CLIA

Active
Agency
Centers for Medicare & Medicaid Services
Status
CLIA Waived devices

Our point-of-care devices carry CLIA-waived status, authorizing use in non-laboratory settings under the Clinical Laboratory Improvement Amendments.

GSA Advantage

Federal vendor
Agency
U.S. General Services Administration
Vehicle
GSA Advantage online ordering

Listed on GSA Advantage, the federal government's online procurement system, enabling federal agencies to purchase ASC products under negotiated contract pricing.

Louisiana State Licenses3 credentials

Louisiana Board of Drug and Device Distributors

Active
Authority
LA State Board
Renewed
2026

Licensed for the manufacture and distribution of drugs and medical devices in the State of Louisiana.

Louisiana Board of Pharmacy

Active
Authority
LA Board of Pharmacy

Authorized to operate as a pharmacy within the State of Louisiana, supporting compliant drug and device distribution operations.

Louisiana Department of Revenue (Resale)

Active
Form
R-1064 Resale
Last verified
2024

State resale and reseller exemption documentation on file. Dealers and distributors may request a copy with their own onboarding paperwork.

International Regulatory Authorizations3 credentials

COFEPRIS (Mexico)

Active
Region
Mexico
Coverage
Cups, dip cards, oral fluid, multi-panel

Federal Commission for the Protection against Sanitary Risk grants regulatory approval to manufacture and distribute ASC products in Mexico.

Health Canada Authorization

Active
Region
Canada
Coverage
Drugs, medical devices, supplements

Authorized by Health Canada for the importation and sale of drugs, medical devices, and nutritional supplements in Canada.

Saudi Food and Drug Authority (SFDA)

Active
Region
Kingdom of Saudi Arabia
Document
MDMA-2-2026-2151

SFDA certification confirms our products meet Saudi Arabian regulatory standards for healthcare and diagnostic device safety, quality, and compliance.

Need verbal or written verification of any credential?

Our compliance team can confirm any certification on this page and provide the underlying document directly.

Request verification
Document request

Need a specific document?

If your procurement or compliance team needs a specific certificate, COI, ISO renewal letter, or other regulatory documentation not displayed publicly, our compliance team will email it directly.

For verbal verification, call 866-526-2873 or email compliance@americanscreeningcorp.com.

Request a document

A compliance specialist will respond directly.

Verifying ASC for a vendor onboarding form?

Our compliance team handles W-9, COI, NDA, supplier qualification, and federal vendor onboarding documents directly.