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 |
|
BloodStor® 100 |
|
CryoStor® CS2 |
|
CryoStor® CS5 |
|
CryoStor® CS10 |
|
Gentle Cell Dissociation Reagent |
|
mTeSR™ Plus |
|
mTeSR™1 |
|
ReLeSR™ |
|
StemSpan™-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
MethoCult™ GF H84434
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
MethoCult™ GF H84435
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
MethoCult™ GF H84535
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
MethoCult™ GF H84534
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
MethoCult™ Cell Wash Medium
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
RosetteSep™ HLA Total Lymphocyte Enrichment Cocktail
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
RosetteSep™ HLA T Cell Enrichment Cocktail
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
RosetteSep™ HLA Lymphoid Cell Enrichment Kit
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
RosetteSep™ HLA Myeloid Cell Enrichment Kit
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
RosetteSep™ HLA Granulocyte Depletion Cocktail
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
RosetteSep™ HLA B Cell Enrichment Cocktail
CE MARKED Class I IVD
TGA Class I IVD
Europe
Australia
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
EasySep™ Direct HLA T Cell Isolation Kit (IVD)
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
Europe
Australia
Canada
EasySep™ Direct HLA B Cell Isolation Kit (IVD)
CE MARKED Class I IVD
TGA Class I IVD
Health Canada Class I IVD
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.