Regulated Products and Instruments

Manufacturing under higher compliance and registering products and instruments with the appropriate regulatory bodies demonstrates STEMCELL Technologies’ commitment to the highest standard of quality and design controls.

Products Manufactured Under Relevant cGMPs

The safety and traceability of ancillary materials are key factors when developing any cell therapy product. To meet your needs, our catalog of ancillary material products manufactured under relevant current Good Manufacturing Practices (cGMPs) is expanding.

Learn more about cGMP and ancillary material qualification >


Expand the section below to see our current list of cGMP products.

cGMP Products

Product Catalog #

BloodStor® 55-5

07937, 07950

BloodStor® 100

07938, 07939, 07951

CryoStor® CS2

07932

CryoStor® CS5

07933, 07949

CryoStor® CS10

07930

Gentle Cell Dissociation Reagent

100-0485

Human Platelet Lysate, Fibrinogen-Depleted

200-0322

mTeSR™ Plus

100-0276

mTeSR™1

85850

ReLeSR™

100-0484

StemSpan™-AOF

100-0130

TeSR™-AOF

100-0401

In Vitro Diagnostic (IVD) Registered Products

STEMCELL has registered a number of In Vitro Diagnostic (IVD) Medical Device products according to country-specific requirements. Several of STEMCELL's products are CE MARKED or are registered with country-specific agencies such as the US FDA, Australian TGA, and Health Canada.

For a full list of registered products and their availability in certain regions, please click below.

Regulated Products

Product
Catalog #
Registrations
Region Availability

SepMate™-15 (IVD)

FDA Class I IVD

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD


United States

Europe

Australia

Canada

SepMate™-50 (IVD)

FDA Class I IVD

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD


United States

Europe

Australia

Canada

Instrumentation

Automation of key laboratory processes can significantly improve the efficiency of your research program. Incorporating an automated platform into your assay or sample processing workflow improves standardization and tracking of processes. It also allows for more effective use of skilled personnel time by increasing throughput and minimizing hands-on time.

To meet both North American and European CE MARKED standards for our line of instrument products, STEMCELL has completed the necessary Electrical Equipment Safety and Electromagnetic Compatibility (EMC)Testing through a recognized third party certification body.

Instruments

Product Catalog #

RoboSep-S™

21000

STEMvision™

22000

RoboSep-16™

23000

Contact STEMCELL Technologies

Our Customer Service, Sales, and Product and Scientific Support departments in North America are available between 6 am and 5 pm Pacific Time (9 am and 8 pm Eastern Time). One of our representatives will be happy to help you by telephone or email. Please complete the form to contact us by email. A representative will get back to you shortly.
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