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 |
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BloodStor® 100 |
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CryoStor® CS2 |
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CryoStor® CS5 |
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CryoStor® CS10 |
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Gentle Cell Dissociation Reagent |
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Human Platelet Lysate, Fibrinogen-Depleted |
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ImmunoCult™ Human CD3/CD28 T Cell Activator |
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ImmunoCult™ Human CD3/CD28/CD2 T Cell Activator |
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ImmunoCult™-XF |
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mTeSR™ Plus |
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mTeSR™1 |
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ReLeSR™ |
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StemSpan™-AOF |
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TeSR™-AOF |
In Vitro Diagnostic (IVD) Products
STEMCELL has a number of In Vitro Diagnostic (IVD) Medical Device products distributed in the US, Canada, Europe, UK and other countries.
For a full list of products and their availability in certain regions, please click below.
Regulated Products
EasySep™ Human Bone Marrow CD138 Positive Selection Kit (IVD)
United States
Europe
Canada
United Kingdom
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.