Regulated Products and Instruments
Registering products and instruments with the appropriate regulatory bodies demonstrates STEMCELL Technologies’ commitment to the highest standard of quality and design controls.
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 |
|---|---|---|---|
|
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 |
|
|
RosetteSep™ DM-M Density Medium |
CE MARKED Class I IVD TGA Class I IVD |
Europe Australia |
|
|
RosetteSep™ DM-L Density Medium |
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.