Iinkonzo zoVavanyo oluKhawulezayo lwe-OEM - I-ODM kunye nokuVeliswa kweeLayibhile zaBucala

Iinkonzo zethu zokuLungisa

UbuNzulu boBugcisa boBugcisa kuwo onke amaNqanaba

Asiyibeki nje uphawu lwakho kwibhokisi - sihambisa ubunjineli bemveliso yokwenyani siqinisekisa ukuba uvavanyo lwechiza lakho le-OEM liyahlangabezana nemimiselo ethile yemarike, imigangatho yezonyango, kunye nesiphelo-okulindelekileyo kumsebenzisi.

I-Custom Assay & Multi-Iiphaneli zeziyobisi

Qwalasela kanye indawo yolawulo efunwa yimarike yakho - ukudibanisa abahlalutyi abaninzi kwisixhobo esinye, ilinganiswe kwiintsingiselo zokuxhatshazwa kwingingqi kunye nokunqunyulwa kwemithetho yendawo.

Ukuya kuthi ga kwi-18 iiparamitha zamachiza kwisixhobo esinye
Amanqanaba okusikwa ngokwesiko (SAMHSA, EMCDDA, AS/NZS, bespoke)
Umchamo, amathe (oral fluid), kunye neenwele zematrices

Cela ikhowuti →

Ubume beSixhobo kunye noYilo loMzimba

Yahlula ibhrendi yakho ngeefomathi ezibonakalayo ezizodwa. Sinikezela ngeemolds ezininzi zezindlu kwaye sinokuyiguqula imiba yefomu kunye noyilo lwemibala ukuze luhambelane nokhetho lwakho lwentengiso.

Imicu, iCassette, Dip-Card, okanye iifomati zeNdebe eDityanisiweyo
Imibala yezindlu zesiko kunye nemizobo yelebhile
Tamper-iitywina ezicacileyo kunye nokukrexeza-jonga ukudityaniswa

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Ukupakishwa kweleyibhile yabucala

Hambisa amava ebrand edibeneyo ukusuka kwibhokisi yangaphandle ukuya kwisingxobo sovavanyo lomntu ngamnye. Iqela lethu loyilo lwangaphakathi - livelisa ubuchwephesha, ummiselo-ubugcisa obuhambelanayo ukuze uvunywe nguwe.

Ngokwesiqhelo-i-nitrogen eprintiweyo-iingxowa zefoyile ezigungxulwayo
Iilwimi ezininzi ze-IFU (Imiyalelo yokuSetyenziswa) ufakelo
Iibhokisi zentengiso ezinophawu kunye nobuninzi besibhedlele-iibhokisi zokubonelela

Cela ikhowuti →

Inkxaso yokuFayila ngokuLawulwayo

Ukuhamba ngemigaqo yezixhobo zonyango kunzima. Sinikezela ngamaxwebhu apheleleyo obugcisa kunye nesikhokelo sobuchwephesha esifunekayo ukuze ubhalise yabucala - ileyibheli yemveliso ye-IVD kwihlabathi liphela.

Iidosi zobugcisa ze-CE IVDR, i-FDA, i-TGA, kunye ne-ANVISA
Ukusebenza kohlalutyo kunye nedatha yokufunda yeklinikhi kwifayile
Izatifikethi zoThengiso lwasimahla (FSC) kunye ne-ISO 13485 docs scope docs

Cela ikhowuti →

Ikhathalogu yeMveliso ye-OEM

Iphothifoliyo yoVavanyo oluBanzi lwe-IVD oluKhawulezayo luyafumaneka kwi-OEM

Uluhlu lwethu lwe-OEM lugqitha kwelona nqanaba liphezulu-lemfuno kwindawo yehlabathi-ye-yoxilongo lokukhathalelwa, zonke zenziwe phantsi kwe-GMP efanayo-isakhelo somgangatho oqinisekisiweyo.

Iziyobisi zokuxhatshazwa - iimvavanyo zomchamo

I-single-panel strips ukuya kwi-18-ikomityi ezidityanisiweyo zeziyobisi zendawo yokusebenza, ikliniki, kunye neenkqubo zovavanyo lwasenkundleni.

I-THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2

Buza Ngoku →

Iziyobisi zokuxhatshazwa - Ulwelo lomlomo

Uvavanyo olungangeneleli lwendlela kunye nendawo yokusebenza yolwelo lomlomo, kuquka iDRUID-izixhobo ezithobelayo zokusetyenziswa komthetho.

I-THCCOCAMP/MAMPOPIEzininzi- Iphaneli

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Iziyobisi zokuxhatshazwa - iimvavanyo zeenwele

Iikiti zokuhlalutya iinwele ezihamba emva kwexesha zibonelela ngefestile ye-90-day yokuchongwa kwezomthetho, i-inshurensi, kunye nokuhlolwa kwengqesho.

90-Imbali yoSukuEzininzi- IphaneliELISA Cutoffs

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Uvavanyo oluKhawulezayo lwezifo ezosulelayo

I-EC

HIV 1/2HBsAgUmkhuhlane A/BI-COVID-19 AgIsifo seengcongconi

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Ukukhulelwa kunye novavanyo lokuchuma

Okuphezulu-nobuntununtunu hCG, LH, kunye novavanyo lwe-FSH kubathengi kunye neemarike zeklinikhi ezinokhetho lwabucala olubanzi-ukhetho lwelebhile.

Uluhlu lwehCGhCG CassetteLH OvulationFSH Ukuyeka ukuya exesheni

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Iimpawu zentliziyo kunye neTumor

Inqaku-lo-nokhathalelo lomgangatho kunye novavanyo olukhawulezileyo lwemeko engxamisekileyo yentliziyo kunye nokuhlolwa kwethumba kwangoko.

Troponin II-BNPD - DimerPSAAFP

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Indlela Esisebenza Ngayo

Ileyibhile yaBucala yeNkqubo yokuVelisa i-OEM

Icociwe ngaphezulu kweminyaka eli-15 ukuthatha imveliso yakho ukusuka kwingcinga ukuya ekusungulweni kwentengiso ngokukhawuleza nangokukhuselekileyo.

Uthethwano lokuqala kunye nokuSayina kwe-NDA

Senza i-NDA efanayo phambi kokuba kwabelwane ngazo naziphi na iinkcukacha zobunini. Iseshoni yokufumanisa ecwangcisiweyo emva koko iquka imarike ekujoliswe kuyo, iiphaneli zamachiza, imigangatho yokusikwa, ukukhethwa kwefomathi, kunye noqikelelo lomthamo wonyaka.
⏱ 1–3 IiNtsuku zeShishini
Isampulu yoMfanekiso kunye noQinisekiso lokuSebenza

Iqela lethu le-R&D liqulunqa kwaye lihlanganise iisampulu zeprototype ezisebenzayo ngokweenkcukacha zakho. Iisampulu zithunyelwa kuwe ukuze uvavanye elebhu yendlu, ukuqinisekiswa kokusebenza kwezonyango, kunye novavanyo lwangaphambili.
⏱ 7–21 IiNtsuku zeShishini
Ukugqityezelwa koMzobo kunye noXwebhu oluLawulayo

Nje ukuba iisampulu zamkelwe, iqela lethu loyilo ligqibezela wonke umsebenzi wobugcisa wokupakisha wabucala-welebhile. Kwangaxeshanye, iqela lethu lemicimbi yolawulo liqulunqa iDossier yobuGcisa yokubhaliswa kwabasemagunyeni kwingingqi yakho.
⏱ 10–15 IiNtsuku zeShishini
Ukwenziwa kweKhontrakthi ye-OEM kunye neMveliso yeSininzi ye-GMP

Ngobugcisa kunye namaxwebhu olawulo avunyiweyo, sisayina isivumelwano sobonelelo lwe-OEM. I-odolo yakho ingena kwimveliso kwi-GMP-amagumbi acocekileyo aqinisekisiweyo aneentambo zokudibanela ezizihambelayo zokwenziwa ngokukhawuleza, okungaguquguqukiyo.
⏱ 30–45 Iintsuku zeKhalenda
Ukukhutshwa okupheleleyo kwe-QC kunye noLungiselelo lwaMazwe ngaMazwe

Iqashiso ngalinye lifumana ibhetri ye-QC epheleleyo - umnqamlezo - iiphaneli zokuphinda usebenze, ubuntununtunu / ukucaciswa, ukuzinza okukhawulezileyo, ukubonakala - phambi kokuba kukhutshwe iSatifikethi soHlahlelo. Emva koko silungelelanisa imithwalo kwindawo yakho yokugcina impahla.
⏱ 5–7 Iintsuku QC + Ukuthumela ngenqanawe

UkuGqwesa kokwenziwa kweMveliso

GMP-eqinisekisiweyo umenzi wekhithi yovavanyo olukhawulezayo

I-ISO Class 8 (100,000) GMP amagumbi okucoca

Zonke i-membrane lamination, ukulungiswa kwe-conjugate pad, kunye nendibano yokugqibela ye-strip yenzeke ngaphakathi koxinzelelo oluqinisekileyo, i-particle-esweni i-ISO Class 8 yamagumbi ahlambulukileyo - enziwe ukuphelisa ungcoliseko kwinqanaba ngalinye.

Ukufuma okungqongqo (RH ≤ 20%) kunye nolawulo lobushushu kuqinisekisa uzinzo lwebhayoloji ye-antibody-antigen conjugates, iqinisekisa ubomi obuqinileyo be-24-enyanga kwishelufu kuyo yonke imigca yemveliso ye-OEM.

ISO 8Igumbi lokucoca iklasi

RH ≤20%Ulawulo lokufuma

24 Mo.Ubomi beShelf

High-Volume Automated Production Lines

CNC-oomatshini abalawulwayo bokuhlikihla, iirobhothi-izikhululo zokuhlanganisa ezincediswayo, kunye nenitrogen ezenzekelayo-ipokhi egungxulwayo-imigca yokutywina ihlangabezana neemfuno zomthamo wehlabathi ngelixa kuncitshiswa umahluko owenziwe ngabantu-ukuzuza i-CV engatshintshiyo kuwo onke amaqashiso.

Umthamo wethu wemveliso udlula iimvavanyo ezigqityiweyo ezingama-100,000 ngosuku, okwenza amaxesha okukhokela imveliso ye-OEM yobuninzi beentsuku ezingama-30 ukuya kwezingama-45 ukusuka kutyikityo lwekhontrakthi.

100K+Iimvavanyo / Usuku

30–45Ixesha lokukhokela usuku

<5% CVUkuhambelana kweNqanaba

ITrasti yoLawulo

Izatifikethi ezaMkelwe kwihlabathi jikelele

Indawo yethu kunye neemveliso zihlangabezana neyona migangatho ingqongqo ye-IVD yehlabathi, inika iimveliso zakho ze-OEM isiseko esivunyiweyo samazwe ngamazwe, esinokuphicothwa.

Jonga isatifikethi

Amabali empumelelo yeqabane

Ukuthenjwa zii-IVD Brands Kumazwekazi amathandathu

Ixesha elide - Intsebenziswano ye-OEM kunye neempawu zokhathalelo lwempilo, abasasazi, kunye nee-arhente zokuthenga zikarhulumente kwihlabathi jikelele.

Ujiko lwabo lwesampulu lwalukhawuleza ngakumbi kunaye nawuphi na omnye umenzi esithe samvavanya. Isiko eli-10-ekomityi yomchamo esiyilungisileyo

UDavid L.UMlawuli wokuThenga-i-IVD, eJamani 🇩🇪

Besifuna i-FDA-amaxwebhu athobelayo kuwo wonke umgca wethu wokuvavanya amayeza abucala-oyileyibhile ngaphakathi kwexesha eliqinileyo. Iqela labo elilawulayo lizise amaxwebhu apheleleyo kwaye liyixhasa ngokupheleleyo inkqubo yethu yobhaliso.

USarah R.I-VP yeeMveliso - uphawu lwezempilo, e-USA 🇺🇸

Emva kweminyaka emithathu yentsebenziswano, ukungaguquguquki kwemveliso kunye nokuphendula kwabo kuhlala kungumzekelo. Siqhuba ngaphezulu kwezigidi ezibini zeeyunithi ngonyaka ngokusebenzisa iziko labo kunye nokungabikho komgangatho obalulekileyo wokubaleka kwirekhodi.

UMohammed K.I-CEO-Inkampani yoDiagnostics, e-UAE 🇦🇪

Imibuzo eqhelekileyo

FAQs zoBudlelwane be-OEM

Konke okufuneka uyazi ngaphambi kokuba uqale iprojekthi yakho yokuqala kunye nathi.

Yintoni i-MOQ yovavanyo lwechiza le-OEM?

5,000 iipcs/SKU zekhasethi kunye neefomathi strip; I-2,000 iipcs zeekomityi ezidibeneyo. Iisampulu zovavanyo (iiyunithi ezingama-50-200) zikhoyo ngaphambi kwee-odolo zorhwebo.

Ingaba isampula ye-OEM ithatha ixesha elingakanani?

Ulungelelwaniso olusemgangathweni:7-10 iintsuku zokusebenza. Uqulunqo lwenoveli olufuna uphuhliso olutsha lohlalutyi okanye ukusikwa ngokwesiko-nokupheliswa kwetitration: iiveki ezi-3 ukuya kwezi-6.

Ngaba unokuxhasa ukubhaliswa kwemveliso kwilizwe lethu?

Ewe - Amaxwebhu oBuchwephesha apheleleyo e-CE IVDR, i-FDA, i-TGA, kunye ne-ANVISA, kunye ne-ISO 13485 certs, i-Declaration of Conformity, kunye neZiqinisekiso zoThengiso lwaMahla (FSC).

Ngaba uyasayina ii-NDAs phambi kweengxoxo zobugcisa?

Ngokuqinisekileyo. I-NDA yokubambisana yenziwa ngaphambi kokuba naluphi na ulwazi lobunikazi lutshintshwe. Ifumaneka ngesiNgesi, isiTshayina, iSpanish, kunye nesiJamani.

Liliphi ixesha eliqhelekileyo lokukhokela imveliso yobuninzi?

Iintsuku zekhalenda ezingama-30–45 emva kokusayina umsebenzi wobugcisa kunye nokuphunyezwa kwekhontrakthi. Ukhetho olukhawulezileyo olukhoyo - xoxa ngexesha lakho kunye neqela lethu lokuthengisa.

Ngaba ndingakhankanya ukunqunyulwa okuqhelekileyo - amanqanaba oxinzelelo?

Ewe. Senza ukuba kube yi-SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, okanye nawuphi na umxhasi-echaziweyo usikiwe-sike. Zonke ziqinisekisiwe ngokuchasene nezinto eziqinisekisiweyo zereferensi ngaphambi kokuveliswa.

Ngaba uyanikezela ngokupakishwa kweleyibhile yabucala epheleleyo?

Ewe - uphawu lwakho kwizindlu zesixhobo, isingxobo sefoil, ikhathoni yangaphandle, kunye ne-IFU. Akukho gama lomenzi kwiimveliso zakho. Iifayile zobugcisa ezihlelekayo ezibonelelweyo ekugqityweni kweprojekthi.

Qalisa Namhlanje