Izinsizakalo Zokuhlola Ezisheshayo ze-OEM - I-ODM & Nokukhiqiza Amalebula Azimele

Amasevisi ethu Okwenza Ngokwezifiso

Ukwenza Ngokwezifiso Okujulile Kuwo Wonke Amazinga

Asimane nje sibeke uphawu lwakho ebhokisini — siletha ubunjiniyela bomkhiqizo wangempela siqinisekisa ukuthi ukuhlolwa kwezidakamizwa ze-OEM kuhlangabezana nemithetho yemakethe ethile, izindinganiso zomtholampilo, kanye nesiphetho-okulindelwe ngabasebenzisi.

I-Custom Assay & Multi-Drug Panels

Lungiselela ngqo iphaneli edingwa yimakethe yakho - ukuhlanganisa abahlaziyi abaningi kudivayisi eyodwa, abalwe kumathrendi okuhlukumeza kwesifunda kanye nokunqanyulwa kwemithetho yendawo.

Kufika kumapharamitha wezidakamizwa ayi-18 kudivayisi eyodwa
Amaleveli okusika-okuvala ngokwezifiso (SAMHSA, EMCDDA, AS/NZS, bespoke)
Umchamo, amathe (oral fluid), kanye namatrices ezinwele

Cela Ikhwothi →

Ifomethi Yedivayisi Nedizayini Ebonakalayo

Hlukanisa umkhiqizo wakho ngamafomethi ahlukile womzimba. Sinikeza isikhunta sezindlu eziningi futhi singashintsha izici zamafomu kanye nezikimu zemibala ukuze zivumelane nentando yakho yemakethe.

I-Strip, Cassette, Dip-Card, noma amafomethi e-Integrated Cup
Imibala yezindlu ngokwezifiso kanye nemidwebo yelebula
I-Tamper-izimpawu ezibonakalayo nokuphinga-hlola ukuhlanganisa

Cela Ikhwothi →

Ukupakishwa Kwelebula Yangasese

Letha okuhlangenwe nakho komkhiqizo okuhlangene kusuka kubhokisi langaphandle kuya esikhwameni sokuhlola ngasinye. Ithimba lethu labaklami bangaphakathi-basendlini likhiqiza umsebenzi wobuciko ochwepheshe, olawulayo-ohambisanayo ukuze uthole imvume yakho.

Ngokwezifiso-i-nitrogen ephrintiwe-izikhwama ze-foil ezishaywayo
Multi-language IFU (Iziyalezo Zokusetshenziswa).
Amakhathoni okuthengisa anegama kanye nenqwaba yesibhedlela-amabhokisi okunikezela

Cela Ikhwothi →

Ukwesekwa Kokugcwalisa Okusemthethweni

Ukuzulazula kwemithetho yemishini yezokwelapha kuyinkimbinkimbi. Sinikezela ngemibhalo ephelele yezobuchwepheshe kanye neziqondiso zochwepheshe ezidingekayo ukuze ubhalise okuyimfihlo-kulebula umkhiqizo we-IVD emhlabeni jikelele.

Amadokhumenti obuchwepheshe e-CE IVDR, FDA, TGA, kanye ne-ANVISA
Ukusebenza kokuhlaziya nedatha yocwaningo lomtholampilo efayeleni
Izitifiketi Zokuthengisa Zamahhala (FSC) kanye ne-ISO 13485 scope docs

Cela Ikhwothi →

Ikhathalogi yomkhiqizo we-OEM

Iphothifoliyo Yokuhlola Okusheshayo Ye-IVD Iyatholakala ku-OEM

Ibanga lethu le-OEM lidlulela ezigabeni-ezifunwayo emhlabeni jikelele-of-ukuxilongwa kokunakekelwa, konke okukhiqizwa ngaphansi kwe-GMP-yohlaka lwekhwalithi eqinisekisiwe.

Izidakamizwa Zokuhlukumeza - Ukuhlolwa Komchamo

Imichilo-iphaneli eyodwa kuya kwezingu-18-zinkomishi ezididiyelwe zezidakamizwa zendawo yokusebenza, ezomtholampilo, kanye nezinhlelo zokuhlolwa kwe-forensic.

I-THCI-COCI-AMP/MAMPI-OPI/BUPI-BZO/MDMAI-FYL/K2

Buza Manje →

Izidakamizwa Zokuhlukumeza - Uketshezi Lomlomo

Ukuhlolwa okungavamisile komgwaqo kanye nokuhlolwa koketshezi lomlomo endaweni yokusebenza, okuhlanganisa i-DRUID-imishini ethobela indlela yokusetshenziswa komthetho.

I-THCI-COCI-AMP/MAMPI-OPIMulti-Iphaneli

Buza Manje →

Izidakamizwa Zokuhlukumeza - Ukuhlolwa Kwezinwele

Izinsiza zokuhlaziya izinwele ezigelezayo zinikeza iwindi lokutholwa kwezinsuku ezingama-90 lokuhlolwa kwezomthetho, umshuwalense, nokuqashwa.

90-Umlando WezinsukuMulti-IphaneliELISA Cutoffs

Buza Manje →

Ukuhlolwa Okusheshayo Kwezifo Ezithathelwanayo

I-CE-imakwe ukuhlolwa okusheshayo kwe-antigen kanye ne-antibody kumaka wezifo ezithathelwanayo ezibucayi emitholampilo nasemphakathini.

I-HIV 1/2HBsAgUmkhuhlane A/BI-COVID-19 AgUmalaleveva

Buza Manje →

Ukuhlolwa Kokukhulelwa Nokuzala

Ukuhlolwa okuphezulu-okuzwela kwe-hCG, LH, kanye ne-FSH kubathengi nezimakethe zomtholampilo ezinezinketho eziyimfihlo ezibanzi-zilebula.

I-hCG StripIkhasethi le-hCGI-LH OvulationUkunqamuka kokuya esikhathini kwe-FSH

Buza Manje →

Izimpawu Zenhliziyo Nezimila

Iphoyinti -

Troponin II-BNPD-DimerI-PSAI-AFP

Buza Manje →

Indlela Esisebenza Ngayo

Inqubo Yokukhiqiza Ilebula ye-OEM yangasese

Icwengisiswe ngaphezu kweminyaka eyi-15 ukuthatha umkhiqizo wakho usuka emcabangweni uye ekwethulweni kwezentengiso ngokushesha nangokuphepha ngangokunokwenzeka.

Ukubonisana Kokuqala Nokusayinda kwe-NDA

Senza i-NDA efanayo ngaphambi kokuthi kwabiwe noma yimiphi imininingwane yokuphathelene. Iseshini yokutholwa ehlelekile ibe isihlanganisa imakethe eqondiwe, amaphaneli ezidakamizwa, amazinga okusika, okuncanyelwayo kwefomethi, kanye nesilinganiso somthamo wonyaka.
⏱ 1–3 Izinsuku Zebhizinisi
Isampula Yesibonelo Nokuqinisekiswa Kokusebenza

Ithimba lethu le-R&D lakha futhi lihlanganise amasampula e-prototype asebenzayo ngokucaciswa kwakho. Amasampuli athunyelwa kuwena ukuze ahlolwe ngelebhu yasendlini, ukuqinisekiswa kokusebenza komtholampilo, nokuhlolwa kwangaphambili kokulawula.
⏱ 7–21 Izinsuku Zebhizinisi
Ukuphothulwa Kwemisebenzi Yobuciko Nokubhalwa Kwemibhalo Yokulawula

Uma amasampuli esegunyaziwe, ithimba lethu lokuklama liphothula wonke umsebenzi wobuciko wokupakishwa-wangasese. Ngesikhathi esifanayo, ithimba lethu lezindaba zokulawula lihlanganisa Idokhumenti Yezobuchwepheshe ukuze ubhalisele iziphathimandla zendawo.
⏱ 10–15 Izinsuku Zebhizinisi
Ukwenziwa Kwenkontileka ye-OEM & Ukukhiqizwa KweMisa ye-GMP

Njengoba umsebenzi wobuciko kanye nemibhalo yokulawula egunyaziwe, sisayina isivumelwano sokuhlinzeka nge-OEM. I-oda lakho lingena ekukhiqizweni nge-GMP-amagumbi okuhlanza aqinisekisiwe anemigqa yokuhlanganisa ezenzakalelayo ukuze kusetshenziswe ngokushesha, okungaguquguquki.
⏱ 30–45 Izinsuku Zekhalenda
Ukukhishwa Okugcwele kwe-QC & Nokugcinwa Kwamazwe Ngamazwe

Yonke indawo ithola ibhethri eliphelele le-QC — iphaneli-amaphaneli okusebenza kabusha, ukuzwela/ukucaciswa okuthile, ukuzinza okusheshisiwe, ukubukeka — ngaphambi kokuthi kukhishwe Isitifiketi Sokuhlaziya. Sibe sesixhumanisa impahla eya endlini yakho yokugcina impahla.
⏱ 5–7 Izinsuku QC + Ukuthumela

Ubuhle Bokukhiqiza

I-GMP-umkhiqizi wekhithi yokuhlola esheshayo eqinisekisiwe

ISO Class 8 (100,000) GMP Cleanrooms

Konke ulwelwesi lwe-membrane, ukulungiswa kwephedi ye-conjugate, kanye nokuhlanganiswa kokugcina komcu kwenzeka ngaphakathi kwamagumbi ahlanzekile e-ISO Class 8 anengcindezi enhle, aqashwe ngeso lokhozi - aklanyelwe ukuqeda ukungcola ngaso sonke isikhathi.

Umswakamo oqinile (RH ≤ 20%) nezilawuli zezinga lokushisa ziqinisekisa ukuzinza kwemvelo kwe-antibody-antigen conjugates, okuqinisekisa ukuphila kweshelufu eliqinile lezinyanga ezingu-24 kuyo yonke imigqa yomkhiqizo we-OEM.

I-ISO 8Ikilasi Lokuhlanza

I-RH ≤20%Ukulawula Umswakama

24 Mo.I-Shelf Life

High-Volume Automated Production Lines

I-CNC-imishini yokuhlinza elawulwayo, irobhothi-iziteshi zokuhlanganisa ezisizwayo, kanye ne-nitrogen ezenzakalelayo-isikhwama esishaywayo-imigqa yokuvala ihlangabezana nezimfuneko zevolumu yomhlaba wonke kuyilapho kunciphisa ukuhlukahluka okubangelwa umuntu-ukuthola i-CV ephansi ngokungaguquki kuzo zonke izindawo.

Umthamo wethu wokukhiqiza udlula izivivinyo eziqediwe eziyi-100,000 ngosuku, okuvumela izikhathi zokuhola zokukhiqiza kwe-OEM eziyizinsuku ezingama-30 kuye kwezingama-45 ukusuka kusiginesha yenkontileka.

100K+Izivivinyo / Usuku

30–45Isikhathi Sokuhola Usuku

<5% CVUkungaguquguquki Okuningi

I-Regulatory Trust

Izitifiketi Ezaziwa Ngamazwe Ngamazwe

Indawo yethu nemikhiqizo ihlangabezana namazinga aqine kakhulu e-IVD womhlaba wonke, okunikeza imikhiqizo yakho ye-OEM isisekelo sekhwalithi esaziwayo emhlabeni wonke, nesifundekayo.

Buka Isitifiketi

Izindaba Zokuphumelela Zozakwethu

Kuthenjwa ama-IVD Brands Kumazwekazi Ayisithupha

Ubambiswano lwe-OEM lwesikhathi eside nemikhiqizo yokunakekelwa kwezempilo, abasabalalisi, nama-ejensi wokuthenga kahulumeni emhlabeni jikelele.

Ukushintsha kwabo amasampula kwakushesha kunanoma yimuphi omunye umkhiqizi esimhlolile. Inkomishi yomchamo yephaneli engu-10-esiyithuthukisile manje isiyi-SKU yethu ephezulu-ethengisayo kuyo yonke imakethe yezempilo yaseYurophu.

UDavid L.Umqondisi Wokuthenga - I-IVD Distributor, Germany 🇩🇪

Besidinga i-FDA-imibhalo ethobelayo yawo wonke umugqa wethu wokuhlola izidakamizwa oyimfihlo-kulebula ngaphakathi komugqa wesikhathi oqinile. Ithimba labo elilawulayo lilethe amaphepha aphelele futhi lasekela ngokugcwele inqubo yethu yokubhalisa.

USarah R.I-VP Yemikhiqizo — I-Healthcare Brand, e-USA 🇺🇸

Ngemva kweminyaka emithathu yokubambisana, ukungaguquguquki kokukhiqiza kwabo kanye nokusabela kwabo kuhlala kuyisibonelo. Sisebenzisa amayunithi angaphezu kwezigidi ezimbili ngonyaka ngokusebenzisa indawo yawo ngaphandle kwerekhodi elingekho ikhwalithi ebalulekile.

UMohammed K.I-CEO - I-Diagnostics Company, e-UAE 🇦🇪

Imibuzo Ejwayelekile

I-OEM Partnership FAQs

Konke odinga ukukwazi ngaphambi kokuqala iphrojekthi yakho yokuqala nathi.

Iyini i-MOQ yokuhlolwa kwezidakamizwa ze-OEM?

5,000 ama-pcs/SKU amafomethi wekhasethi nama-strip; Ama-pcs angu-2,000 wezinkomishi ezihlanganisiwe. Amasampula okuhlola (amayunithi angama-50–200) atholakala ngaphambi kwama-oda okuthengisa.

Kuthatha isikhathi esingakanani ukusampula kwe-OEM?

Ukucushwa okujwayelekile:7–10 izinsuku zebhizinisi. Ukwakhiwa kwenoveli okudinga ukuthuthukiswa kohlaziyo olusha noma ukusika ngokwezifiso-kunqanyulwa kwesihloko: amaviki angu-3–6.

Ungakwazi yini ukusekela ukubhaliswa komkhiqizo ezweni lethu?

Yebo - Amadokhumenti Aphelele Ezobuchwepheshe e-CE IVDR, FDA, TGA, ne-ANVISA, kanye nezitifiketi ze-ISO 13485, Isimemezelo Sokuvumelana, Nezitifiketi Zokuthengisa Zamahhala (FSC).

Ingabe uyawasayina ama-NDA ngaphambi kwezingxoxo zobuchwepheshe?

Nakanjani. I-NDA yokubambisana yenziwa ngaphambi kokuba noma yiluphi ulwazi lobunikazi luhwetshwe. Itholakala ngesiNgisi, isiShayina, iSpanishi, nesiJalimane.

Sithini isikhathi sokuhola esijwayelekile sokukhiqiza ngobuningi?

30–45 izinsuku zekhalenda ngemva kokusayina umsebenzi wobuciko-ukuvalwa kanye nokwenziwa kwenkontileka. Izinketho ezisheshayo ziyatholakala - xoxa ngomugqa wakho wesikhathi nethimba lethu labadayisi.

Ngingakwazi ukucacisa amazinga okugxilisa okusikiwe-okuvala ngokwezifiso?

Yebo. Sakha i-SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, nanoma yiliphi iklayenti-okunqunyiwe-okunqunyiwe. Konke kuqinisekisiwe ngokumelene nezinto eziyisethenjwa eziqinisekisiwe ngaphambi kokukhiqizwa.

Ingabe uyakunikeza okugcwele ngelebula yangasese?

Yebo - ukufaka uphawu lwakho kundlu yedivayisi, isikhwama se-foil, ibhokisi elingaphandle, kanye ne-IFU. Alikho igama lomkhiqizi emikhiqizweni yakho. Amafayela obuciko ahlelekayo ahlinzekwe lapho kuqedwa iphrojekthi.

Qalisa Namuhla