OEM Serivise Yihuse - ODM & Ibirango byigenga Gukora

Serivisi zacu bwite

Ubuhanga bwimbitse bwa tekinike kuri buri Rwego

Ntabwo dushyira ikirango cyawe gusa kumasanduku - dutanga ibicuruzwa byukuri byerekana ko ibizamini bya OEM byujuje ubuziranenge byamasoko, amahame yubuvuzi, kandi amaherezo - ibyifuzo byabakoresha.

Custom Assay & Multi - Ibiyobyabwenge

Hindura neza ikibanza isoko yawe isaba - guhuza analyite nyinshi mugikoresho kimwe, ugahindura uburyo bwo guhohotera mukarere no kugabanya amabwiriza -

Ibipimo bigera kuri 18 byibiyobyabwenge mugikoresho kimwe
Gukata ibicuruzwa - kurwego (SAMHSA, EMCDDA, AS / NZS, bespoke)
Inkari, amacandwe (amazi yo mu kanwa), hamwe na matrices yimisatsi

Saba Amagambo →

Imiterere y'ibikoresho & Igishushanyo mbonera

Tandukanya ikirango cyawe hamwe nimiterere yihariye yumubiri. Dutanga amazu menshi yimyubakire kandi turashobora guhindura ibintu hamwe na sisitemu y'amabara kugirango uhuze isoko yawe.

Strip, Cassette, Dip - Ikarita, cyangwa Imiterere Igikombe
Koresha amabara yimyubakire hamwe nibirango bishushanyije
Tamper - kashe igaragara nubusambanyi - kugenzura kwishyira hamwe

Saba Amagambo →

Ibirango byihariye

Tanga ubunararibonye buranga kuva kuri karito yo hanze kugeza kumufuka wikizamini. Itsinda ryacu -

Custom - icapiro rya azote - flush foil pouches
Multi - ururimi IFU (Amabwiriza yo Gukoresha) shyiramo
Ikarita yerekana ibicuruzwa hamwe nibitaro byinshi - udusanduku two gutanga

Saba Amagambo →

Inkunga yo Gutanga Amabwiriza

Kuyobora amabwiriza yubuvuzi biragoye. Dutanga ibyangombwa bya tekiniki byuzuye hamwe nubuyobozi bwinzobere bukenewe kugirango wandike ibicuruzwa byawe - label IVD ibicuruzwa kwisi yose.

Dosiye ya tekiniki ya CE IVDR, FDA, TGA, na ANVISA
Imikorere yisesengura & ivuriro ryamakuru kuri dosiye
Ibyemezo byo kugurisha kubuntu (FSC) na ISO 13485 urugero rwa dosiye

Saba Amagambo →

OEM Cataloge y'ibicuruzwa

Byuzuye IVD Ikizamini Cyihuta Portfolio Iraboneka kuri OEM

Urwego rwacu rwa OEM ruri hejuru cyane - ibyiciro bisabwa murwego rwisi - ya - gusuzuma indwara, byose bikozwe murwego rumwe rwa GMP - byemewe.

Ibiyobyabwenge byo gukoresha nabi - Kwipimisha inkari

Ingaragu

THCCOCAMP / MAMPOPI / BUPBZO / MDMAFYL / K2

Baza Noneho →

Ibiyobyabwenge byo gukoresha nabi - Amazi yo mu kanwa

Non - invasive kumuhanda hamwe nakazi kahantu hapimwa amazi yo mu kanwa, harimo DRUID - uburyo bwujuje ibyangombwa byo gukoresha amategeko.

THCCOCAMP / MAMPOPIIgice kinini

Baza Noneho →

Ibiyobyabwenge byo guhohoterwa - Kwipimisha umusatsi

Isesengura ryimisatsi yimyenda itanga 90 - umunsi wo kumenya umunsi kugirango amategeko, ubwishingizi, no gusuzuma akazi.

90 - Amateka yumunsiIgice kininiELISA Cutoffs

Baza Noneho →

Indwara Zandura Ibizamini Byihuse

CE - yaranze antigen na antibody byihuse kubimenyetso byindwara zandura zikomeye mubuvuzi no mubaturage.

VIH 1/2HBsAgIbicurane A / B.COVID - 19 AgMalariya

Baza Noneho →

Ibizamini byo Gutwita & Uburumbuke

Hejuru - sensitivite hCG, LH, na FSH ibizamini kumasoko yabaguzi nubuvuzi hamwe nibigenga byigenga - ibirango.

HCGHCG CassetteLH OvulationFSH Gucura

Baza Noneho →

Ibimenyetso byumutima & Tumor

Ingingo - ya - kwita kubipimo byujuje ubuziranenge no kugereranya byihuse byihutirwa byumutima byihutirwa no gusuzuma ibibyimba hakiri kare.

Troponin I.BNPD - DimerPSAAFP

Baza Noneho →

Uburyo Dukora

Ikirango cyihariye OEM Igikorwa cyo Gukora

Kunonosorwa mumyaka 15 kugirango ufate ibicuruzwa byawe mubitekerezo ujye kubucuruzi byihuse kandi mumutekano bishoboka.

Impanuro Yambere & Gusinya NDA

Dukora mutuelle ya NDA mbere yuko ibintu byose bisangirwa. Igice cyo kuvumbura cyubatswe noneho gikubiyemo isoko, intego yibiyobyabwenge, gukata - guhagarika ibipimo, guhitamo imiterere, hamwe nubunini bwumwaka.
Days Iminsi y'akazi
Guhitamo icyitegererezo no kwemeza imikorere

Itsinda ryacu R&D ritegura kandi riteranya icyitegererezo cya prototype ikora kubisobanuro byawe. Ingero zoherejwe kuri - muri laboratoire yo munzu, kwemeza imikorere yubuvuzi, no kugenzura pre - gusuzuma.
⏱ 7–21 Iminsi Yakazi
Ibikorwa Byanyuma Kurangiza & Inyandiko zigenga

Ingero zimaze kwemezwa, itsinda ryacu ryashushanyije rirangiza ibyigenga byose. Icyarimwe, itsinda ryacu rishinzwe kugenzura imikorere ya Dossier ya Tekinike yo kwiyandikisha mubuyobozi bwibanze.
⏱ 10-15 iminsi yubucuruzi
OEM Amasezerano Yakozwe & GMP Umusaruro rusange

Hamwe nibikorwa byubuhanzi hamwe namabwiriza yemewe, dusinya amasezerano yo gutanga OEM. Ibicuruzwa byawe byinjira mubikorwa muri GMP - ubwiherero bwemewe hamwe numurongo uteganijwe guterana byihuse, byinjira.
⏱ 30-45 Iminsi Yumunsi
QC Yuzuye Isohora & International Logistics

Buri mugabane uhura na bateri yuzuye ya QC - umusaraba - panne reaction, sensitivite / umwihariko, kwihuta kwihuta, kugaragara - mbere yicyemezo cyisesengura gitangwa. Turahita duhuza ibicuruzwa mububiko bwawe.
⏱ Iminsi 5-7 QC + Kohereza

Gukora neza

GMP - byemejwe byihuse byogukora ibikoresho

ISO Icyiciro cya 8 (100.000) GMP Isuku

Ibibyimba byose bya lamination, gutegura padi ya conjugate, hamwe no guteranya imirongo ya nyuma bibaho imbere yumuvuduko ukabije, ibice - byakurikiranwe mubwiherero bwa ISO Class 8 - byakozwe kugirango bikureho umwanda kuri buri ntambwe.

Ubushuhe bukabije (RH ≤ 20%) hamwe nubugenzuzi bwubushyuhe byemeza ko biologiya ihagaze neza ya antibody - antigen conjugates, itanga ubuzima bwiza bwamezi 24 - ukwezi kumurongo wose wibicuruzwa bya OEM.

ISO 8Icyumba cy'isuku

RH ≤20%Kugenzura Ubushuhe

24 Mo.Ubuzima bwa Shelf

Hejuru - Umubumbe wa Automatic Automatic Line

CNN

Ubushobozi bwacu bwo gukora burenga ibizamini 100.000 byarangiye kumunsi, bituma OEM itanga umusaruro mugihe cyiminsi 30 kugeza 45 uhereye kumasezerano.

100K +Ibizamini / Umunsi

30-45Umunsi Uyobora Igihe

<5% CVGuhoraho

Icyizere kigenga

Impamyabumenyi Yemewe ku rwego mpuzamahanga

Ibikoresho byacu nibicuruzwa byujuje ubuziranenge bwa IVD ku isi, biha ibicuruzwa byawe OEM bizwi ku rwego mpuzamahanga, bifite ireme ryiza.

Reba Icyemezo

Intsinzi Yabafatanyabikorwa

Yizewe na IVD Ibiranga Kumugabane wa gatandatu

Igihe kirekire - ubufatanye bwa OEM nibirango byubuzima, abagabura, hamwe n’ibigo bitanga amasoko ya leta kwisi yose.

Guhitamo kwabo kwihuta kurenza abandi bakora uruganda twasuzumye. Umugenzo 10 - panne yinkari igikombe dufatanije - twateje imbere ubu ni isonga yacu - kugurisha SKU kumasoko yubuzima bwakazi bwi Burayi.

David L.Umuyobozi ushinzwe amasoko - Umugabuzi wa IVD, Ubudage 🇩🇪

Twari dukeneye FDA - ibyangombwa byujuje ibyigenga byose - label yo gupima ibiyobyabwenge mugihe gito. Itsinda ryabo rishinzwe kugenzura ryatanze dosiye zuzuye kandi zishyigikira byimazeyo gahunda yo kwiyandikisha.

Sarah R.VP y'ibicuruzwa - Ikirango cyita ku buzima, Amerika 🇺🇸

Nyuma yimyaka itatu yubufatanye, umusaruro wabo uhoraho no kwitabira bikomeza kuba intangarugero. Dukoresha ibice birenga miriyoni ebyiri buri mwaka binyuze mubikoresho byabo hamwe na zeru zujuje ubuziranenge zanditse.

Mohammed K.Umuyobozi mukuru - Isosiyete ishinzwe gusuzuma, UAE 🇦🇪

Ibibazo bisanzwe

Ibibazo byubufatanye bwa OEM

Ikintu cyose ukeneye kumenya mbere yo gutangira umushinga wawe wambere natwe.

MOQ niyihe yo gupima imiti ya OEM?

5.000 pcs / SKU kuri cassette na format ya strip; 2000 pc kubikombe byahujwe. Isuzuma ry'icyitegererezo (ibice 50–200) biboneka mbere yubucuruzi.

Icyitegererezo cya OEM gifata igihe kingana iki?

Igenamiterere risanzwe: iminsi y'akazi 7-10. Ibisobanuro bishya bisaba iterambere rishya rya analyte cyangwa gukata kugiti - guhagarika titre: ibyumweru 3-6.

Urashobora gushyigikira kwandikisha ibicuruzwa mugihugu cyacu?

Yego - kuzuza Dossier ya Tekinike ya CE IVDR, FDA, TGA, na ANVISA, wongeyeho ISO 13485 cert, Itangazo ryujuje ibisabwa, hamwe nicyemezo cyo kugurisha kubuntu (FSC).

Urasinya NDAs mbere yo kuganira tekinike?

Rwose. Mugenzi wa NDA bikorwa mbere yamakuru yose yihariye. Biboneka mu Cyongereza, Igishinwa, Icyesipanyoli, n'Ikidage.

Nibihe bisanzwe umusaruro rusange uyobora igihe?

Iminsi 30-45 nyuma yikimenyetso cyibikorwa - kuzimya no kurangiza amasezerano. Amahitamo yihuse arahari - muganire ku gihe cyanyu hamwe nitsinda ryacu ryo kugurisha.

Nshobora kwerekana ibicuruzwa byaciwe - kurwego rwo kwibanda?

Yego. Duteganya kuri SAMHSA, EMCDDA, AS / NZS 4308, UK WDTG, cyangwa umukiriya uwo ari we wese - byasobanuwe gukata - guhagarika. Byose byemejwe kubikoresho byemewe mbere yumusaruro.

Utanga ibirango byuzuye byapakiye?

Yego - ikirango cyawe kubikoresho byububiko, umufuka wuzuye, ikarito yo hanze, na IFU. Nta zina ryabakora kubicuruzwa byawe. Guhindura dosiye yubuhanzi yatanzwe kurangiza umushinga.

Tangira Uyu munsi