Chat with an Expert

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

19671

EasySep™ Direct HLA T Cell Isolation Kit

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD


Europe

Australia

Canada

19671RF

EasySep™ Direct HLA T Cell Isolation Kit

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD


Europe

Australia

Canada

19684

EasySep™ Direct HLA B Cell Isolation Kit

CE MARKED Class I IVD

TGA Class I IVD

Health Canada Class I IVD


Europe

Australia

Canada

19684RF

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