Regulated Products at STEMCELL

In Vitro Diagnostic (IVD) Registered Products

STEMCELL Technologies has registered a number of In Vitro Diagnostic (IVD) Medical Device products according to country specific requirements. For a full list of registered products and their availability in certain countries, please click below.

Registering products demonstrates STEMCELL’s commitment to the highest standard of quality and design controls. Many of STEMCELL's products are CE Mark or are registered with country specific agencies such as the US FDA , Australian TGA, and Health Canada.

Regulated Products

Part ID	Product	Registrations	Region Availability
84434	MethoCult™ GF H84434	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84444	MethoCult™ GF H84444	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84435	MethoCult™ GF H84435	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84445	MethoCult™ GF H84445	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84535	MethoCult™ GF H84535	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84545	MethoCult™ GF H84545	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84534	MethoCult™ GF H84534	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
84544	MethoCult™ GF H84544	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
87700	MethoCult™ Cell Wash Medium	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
15263HLA	RosetteSep™ HLA Total Lymphocyte Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15283HLA	RosetteSep™ HLA Total Lymphocyte Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15061HLA	RosetteSep™ HLA T Cell Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15081HLA	RosetteSep™ HLA T Cell Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15271HLA	RosetteSep™ HLA Lymphoid Cell Enrichment Kit	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15272HLA	RosetteSep™ HLA Myeloid Cell Enrichment Kit	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15664HLA	RosetteSep™ HLA Granulocyte Depletion Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15684HLA	RosetteSep™ HLA Granulocyte Depletion Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15064HLA	RosetteSep™ HLA B Cell Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15084HLA	RosetteSep™ HLA B Cell Enrichment Cocktail	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15725	RosetteSep™ DM-M Density Medium	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
15705	RosetteSep™ DM-L Density Medium	CE MARKED Class I IVD TGA Class I IVD	Europe Australia
85415	SepMate™-15	FDA Class I IVD CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	United States Europe Australia Canada
85450	SepMate™-50	FDA Class I IVD CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	United States Europe Australia Canada
89671	EasySep™ Direct HLA T Cell Isolation Kit	CE MARKED Class I IVD TGA Class I IVD Health Canada Class I IVD	Europe Australia Canada
89684	EasySep™ Direct HLA B Cell Isolation Kit	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 while increasing throughput and minimizing hands-on time, thus allowing for more effective use of skilled personnel time.

STEMCELL Technologies has completed the necessary Electronic Safety and Electromagnetic Compatibility (EMC)Testing to meet both North American and European CE MARKED standards through a recognized 3rd party certification body for our instrument line of products.

Instruments

Part ID	Product
20000	RoboSep™
21000	RoboSep-S™
22000	STEMvision™
23000	RoboSep-16™
30000	ClonaCell™ EasyPick