Quality Assurance and Accreditation

Cellabs Pty Ltd develops and manufactures high quality IVD products for the tropical and infectious disease diagnostics market. We have an outstanding reputation in the industry for over 30 years. It is our commitment to continue delivering the same high quality diagnostic products globally.

Cellabs Pty Ltd maintains a Quality Management System that complies with International Standards for IVD Medical Device Manufacturing, ISO13485.

Cellabs obtained its first Australian Therapeutics Goods Administration (TGA) accreditation in 1996. Following a successful transition into the TGA IVD Framework of 2014, Cellabs currently lists its products under the Australian Register of Therapeutics Goods (ARTG). 

Since 2003, Cellabs' compliance to  has maintained its European Union (EU) IVD manufacture certification through CE Marking, EC Directive 98/79/EC, a mandatory conformity requirement for marketing IVDs in the European Economic Area (EEA).

Accreditation:

Australian Therapeutics Goods Administration (TGA)

Quality Management System Certificate download here

Conformity Assessment Certificate download here

TGA Declaration of Conformity download here

Conformite European (CE Marking)  EC Directive 98/79/EC

CE Marking Certificate download here

EC Declaration of Conformity download here

International Standard ISO 13485 for Medical Device/IVD Manufacturing

ISO13485:2016 Certificate download here