CE-marking and the guideline 98/79/EC

The purpose of the guideline 98/79/EC, also known as In Vitro Diagnostic Medical Device Directive, issued by the European Union, is to establish and to guarantee a uniform quality standard of medical diagnostic products within the EU.

All in vitro diagnostic medical devices, sold or given away within the EU, intended to be used in vitro for the examination of specimens derived from the human body must comply with this Directive. The CE-marking logo on the packaging of ZytoVision’s products is the visible evidence that the product fulfils all requirements of applicable Directives and can be sold throughout the EU and to EFTA countries.

Products that are exclusively used for research purposes or are sold outside the EU or EFTA countries are clearly marked with “For research use only”. Nevertheless, these products are also manufactured by ZytoVision according to the same high quality standards.

Please ask your lokal dealer for availability of CE-marked ZytoLight or ZytoFast products.

Graphic symbols used in the labeling of our IVD Products

Only the English translation is shown. Please contact helptech@zytovision.com for other European language translations.

	Product conform to the IVD Directive		Number of Tests
	In Vitro Diagnostic Medical Device		Manufacturer
	Batch code		Store at temperature interval
	Catalogue number		Expires
	Warning, read enclosed documents		Positive control
	Read Instructions for Use		Negative control
			Control