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 |
|
Gentle Cell Dissociation Reagent |
|
Human Platelet Lysate, Fibrinogen-Depleted |
|
mTeSR™ Plus |
|
mTeSR™1 |
|
ReLeSR™ |
|
StemSpan™-AOF |
|
TeSR™-AOF |
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
SepMate™-15 (IVD)
FDA Class I IVD
CE MARKED General IVD (98/79/EC)
TGA Class I IVD
Health Canada Class I IVD
MHRA General IVD
United States
Europe
Australia
Canada
United Kingdom
SepMate™-50 (IVD)
FDA Class I IVD
CE MARKED General IVD (98/79/EC)
TGA Class I IVD
Health Canada Class I IVD
MHRA General IVD
United States
Europe
Australia
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.