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

84434, 84444

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD

Europe

Australia

Canada

MethoCult™ GF H84435

84435, 84445

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD

Europe

Australia

Canada

MethoCult™ GF H84535

84535, 84545

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD

Europe

Australia

Canada

MethoCult™ GF H84534

84534, 84544

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD

Europe

Australia

Canada

MethoCult™ Cell Wash Medium

87700

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD

Europe

Australia

Canada

RosetteSep™ HLA Total Lymphocyte Enrichment Cocktail

15263HLA, 15283HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ HLA T Cell Enrichment Cocktail

15061HLA, 15081HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ HLA Lymphoid Cell Enrichment Kit

15271HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ HLA Myeloid Cell Enrichment Kit

15272HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ HLA Granulocyte Depletion Cocktail

15664HLA, 15684HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ HLA B Cell Enrichment Cocktail

15064HLA, 15084HLA

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ DM-M Density Medium

15725

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

RosetteSep™ DM-L Density Medium

15705

CE MARKED Class I IVD

TGA Class I IVD

Europe

Australia

SepMate™-15 (IVD)

85415

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)

85450

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)

89671

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)

89684

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.

Instruments

Product Catalog #

RoboSep-S™

21000

STEMvision™

22000

RoboSep-16™

23000