The product remains unchanged

The introduction of separate IVD and RUO versions does not affect the product itself.
The IVD and RUO versions are manufactured using the same:

• Materials
• Manufacturing processes
• Quality controls
• Product specifications

The update does not affect product quality or analytical performance. The differences between the versions are limited to product labeling, regulatory status and article number.

Frequently asked questions

Why is Mercodia introducing separate IVD and RUO versions?

The separate versions provide a clearer distinction between regulatory statuses in different markets and make it easier to identify the appropriate product version.

When did the new RUO product versions become available?

The new RUO product versions became available on 1 November 2026. Current information about product versions, article numbers and regulatory status is available on the relevant product pages.

Will existing IVD article numbers change?

No. Existing IVD products will retain their current article numbers.

Will the corresponding RUO versions have new article numbers?

Yes. The corresponding RUO versions will be assigned separate article numbers.

Is the product different in the RUO version?

No. The IVD and RUO versions are manufactured using the same materials, manufacturing processes, quality controls and product specifications.

The differences between the versions are limited to product labeling, regulatory status and article number.

Will product quality or analytical performance change?

No. The update does not reflect any change in product quality or analytical performance.

Where can I find information about available product versions?

Our updated product pages will provide current information about product availability and regulatory status for different markets.

Select your country and use the regulatory status filter to explore relevant products.

Questions about the update?

If you have questions about product versions, article numbers or availability in your market, please contact your local Mercodia representative.

Facebook

This field is for validation purposes and should be left unchanged.

Name(Required)

First

Email(Required)

Company/Organisation

Country(Required)

Please SelectAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongoCongo, Democratic Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzechiaCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatiniEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth MacedoniaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussian FederationRwandaRéunionSaint BarthélemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwedenSwitzerlandSyria Arab RepublicTaiwanTajikistanTanzania, the United Republic ofThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkmenistanTurks and Caicos IslandsTuvaluTürkiyeUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaViet NamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands

Industry

Please SelectAcademiaBiotechnologyCRO/Service ProvidersHealthcarePharmaceuticalOthers

Message(Required)

By submitting the information above, including your message, email, and phone number, you consent to us contacting you through these channels in response to your inquiry and acknowledge that you have read and agree to Mercodia’s privacy policy.

Submit