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Quality Certificates and FAQs

Find all your Bio-Techne and Bio-Teche brand quality documents in one place, as well as a list of frequently asked quality questions.

If you can't find what you're looking for please contact us and we'll be happy to help.

Quality Management Systems Manual

Download our QMS manual here: R&D Systems Quality Manual

R&D Systems is committed to the highest level of quality in the manufacture, sale and support of our products; and to operate in a manner that minimizes environmental impacts and provides effective stewardship of the environment.


Industry Standards and Regulatory Credentials

Our policies are in conformance with the requirements of the Code of Federal Regulations (21 CFR 820); Quality System Regulations for Medical Devices, ISO 13485:2016 Standard, ISO 9001:2015 Standard, and ISO 14001:2015 Standard, the In Vitro Diagnostic Directive 98/79/EC and the Canadian Medical Device Regulations.



Bio-Techne Ltd – Europe ISO9001 certificate

Bio-Techne Ltd – Europe ISO14001 certificate

Bio-Techne S.r.l. – Italy ISO Certificate

Bio-Techne ISO 13485

Bio-Techne Instrument Quality certificates

Cyvek 13485 Certification


R&D Systems

R&D Systems ISO 13485 Certificate

R&D Systems ISO 9001 Certificate

R&D Systems ISO 14001 Certificate

R&D Systems MDSAP Certificate

R&D Systems Flowery Branch ISO Certificate



Tocris Bioscience – ISO Certification


Exosome - Accreditation and Licensure

Exosome ISO 13485 Certificate

The College of American Pathologists (CAP)

Clinical Laboratory Improvement Amendments (CLIA)

Massachusetts Department of Health

California Department of Public Health

Maryland Department of Health

Rhode Island Department of Health

New York State Department of Health

Pennsylvania Department of Health

DAKKS Accreditation 15189



ISO-13485:2016 Certificate

MDSAP Certificate

CLIA - View our Licenses and Accreditations

HIPAA Privacy Notice



Statement Regarding R&D Systems Reagents and Testing with Animal and/or Human Cells/Tissues

In conjunction with outside collaborators, some of R&D Systems research reagents are tested using embryonic, fetal, or adult human cells and tissues. All cells and tissues are collected under the ethical and regulatory considerations of each Institute's Internal Review Board. R&D Systems follows all state and federal laws and policies relating to its research and business practices.

Affidavit for Animal and Human Derived Products/Assurance of Sourced Animal Health and HIV and Hepatitis Testing

Affidavit for Natural Rubber Latex

TSE/BSE policy

R&D Systems®Quality System FAQs


Is R&D Systems registered with the U.S. Food and Drug Administration (FDA)?

R&D Systems is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act, registration number 2182501, and is routinely inspected by the FDA. Our In Vitro Diagnostic (IVD) products are manufactured under the Food and Drug Administration's Quality System Regulations and compliant with ISO 13485. Our Research Use Only products are in compliance with ISO 9001; they are freely marketed in the U.S.; and are in compliance with all U.S. laws and regulations.


How do you ensure "product quality"?

Product quality is ensured from beginning to end with raw materials being controlled and inspected, in-process and final product testing against written specifications, and final inspection based on published sampling plans before a product is released for sale. Internal Quality Audits are performed periodically by qualified staff and vendor audits are performed on an as needed basis. Effectiveness checks are made through review and monitoring of product complaints, non-conforming materials, and corrective and preventative action programs.


Do you provide products qualified for in vitro diagnostic (IVD) use?

R&D Systems manufactures hematology controls and calibrators and several ELISA kits that are for in vitro diagnostic (IVD) use. As such, we are an FDA registered facility and comply with Quality System Regulations (QSR). Our registration number is 2182501.


Are your products CE-marked?

The majority of our IVD products are CE marked to the In Vitro Diagnostic Directive 98/79/EC (please refer to the specific product insert for more details).