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CE IVD Labelling of Pastettes (Pasteur or Plastic Pipette)

Can Pastettes (Pasteur or Plastic Pipette) carry the CE IVD label?

hand-pastette-4Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) provides the regulatory framework for manufacturers and for authorised representatives who wish to place in vitro diagnostic (IVD) products on the EU common market.  Products that satisfy the regulatory requirements are permitted to carry the CE IVD mark.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

For a number of years, there has been confusion on whether products such as pipettes  could carry the CE IVD mark.

In 2012 the European Commission Directorate General for Health and Consumers issued guidelines on certain products to clarify the position on CE IVD marking.

http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/files/meddev/2_14_1_rev2_ol_en.pdf

Further guidelines were issued in 2014.

http://ec.europa.eu/growth/sectors/medical-devices/documents/borderline/files/borderline_manual_ol_en.pdf

In both these sets of guidelines it is very clear that pipettes, are not permitted to carry the CE IVD mark as they are for general laboratory use only and are not specifically intended to be used for in vitro diagnostic examination.

Hence all such pipettes under the Alpha Laboratories brand of Pastettes will not be CE IVD marked once current stocks are depleted.

The products will still be available and manufactured to the same high standards – they will just not carry the CE IVD mark.

If you require further clarification please contact us.

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Pasteur/Plastic Pipette Brochure

Take a look at the Pasteur/Plastic Pipette brochure. It’s full of useful information about the complete range of transfer and pasteur pipettes on offer, plus case studies and more.

It shows the full range of Pastettes (plastic or pasteur pipettes).  They are available in over 50 designs and can be used for many specialist as well as general purpose requirements. They provide a safe and convenient alternative to glass pipettes, available in numerous shapes and sizes.

Pastettes (plastic or pasteur pipettes) are available in sterile, as well as simply packaged non-sterile pack formats. Sterile inner packs of 20, 10 or single wrap Pastettes combine the security of aseptic transfers with the economy of use that suits your needs.

Pastettes are also available for custom requirements. Call Alpha Laboratories to discuss your specific design and packaging solutions.

Click this link to download your copy: Pasteur Pipette (Pastette) Brochure 2015 v1.1

Alternatively, explore the full range on-line on the Alpha Laboratories main website – Pastettes.

 

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Dual Bulb Exact Volume Pastettes (Pasteur or plastic pipettes) Now Available in Packs of 500

Dual-Bulb PastettesDual Bulb Exact Volume Pastettes - Packs of 500 now available® deliver foolproof simplicity for exact volume dispensing and are now available in convenient packs of 500. These are the simplest pipette you will ever use to deliver a fixed, small, measured volume of liquid, fast. Simply squeeze the upper bulb to fill, and squeeze again to dispense the precise volume. Also known as Exact Volume Pipettes, these space saving, economical, single piece, disposable liquid transfer devices are a quick and easy alternative to conventional pipettes and tips.

They are particularly useful for untrained hands making them an ideal component of self test or point-of-care diagnostic kits. However, now they are generally available in smaller pack sizes, they provide a practical option across a wide range of general laboratory applications requiring fixed, small volume sample delivery. Available in a range of volumes from 20-250µl, they deliver with an accuracy of +/- 10%.

Why not see for yourself just how easy small volume transfers can be?  Dual Bulb Exact Volume Pastettes – packs of 500.

Find out more about Dual-Bulb Pastettes

 

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Dedicated Pasteur/Plastic Pipettes Website

Louis Pasteur - Inventor- of the Pasteur PipetteWhatever your application, from standard liquid transfer procedures to unique or unusual uses, this new website will help you find exactly the pipette you require.

An exclusive resource www.pasteur-pipette.com provides everything you need to know about Pasteur pipettes. Discover the history generating from Louis Pasteur’s invention, to the evolution of Alpha Laboratories’ extensive range of plastic Pastettes developed in response to customer needs.

Covering a wide range of uses within Life Sciences, Industrial and Clinical environments you can explore more than 50 models to find the right pipette for your requirements. Plus, you can read of other users real life stories of routine or novel applications.

Pastette has become a globally recognised name for quality manufactured Pasteur pipettes delivering the highest performance. You can choose from Graduated, Non-Graduated, Fine Tip or Micro Pastettes. For specific applications there are also the Dual-Bulb, Paddle or Aspirator Pastettes, each bringing unique features for additional functionality, convenience or safety.

If you still can’t find the perfect pipette for your particular use, Alpha Laboratories also offers a Custom Pastette Design Service that can create a bespoke model, length, volume, colour or packaging format. Alpha Laboratories has over 20 years experience creating made to order pipette designs to exact customer specifications giving you confidence when you request a quotation for your own specific requirements.

 

 

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