Zogulitsa
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1. Mankhwala osokoneza bongo Mayeso 2. Kuyesedwa kwa matenda opuma 3. Mayeso a Matenda Opatsirana 4. Mayeso a Umoyo Wamayi 5. Mayeso a Cardiac Marker 6. Chotupa Marker Test 7. Kuyesa kwa Chizindikiro Chotupa 8. Mayeso a Chowona Zanyama
Za Ife
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1. mbiri ya kampani 2. certification 3. Ulendo wa Fakitale
Yankho Ntchito Nkhani Lumikizanani Nafe
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Kuti tikupatseni zokumana nazo zabwino kwambiri, timagwiritsa ntchito matekinoloje ngati makeke kusunga ndi/kapena kupeza zidziwitso zapachipangizo. Kuvomereza matekinolojewa kudzatithandiza kukonza zinthu monga kusakatula kapena ma ID apadera patsamba lino. Kusavomereza kapena kuchotsa chilolezo, kungawononge zinthu zina ndi ntchito zina.
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Kana ndi kutseka
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15+
Zaka Zopanga
40+
Ma Analytes Ovomerezeka a Mankhwala
200M+
Mayesero Opangidwa Pachaka
60+
Mayiko Otumiza kunja
Ntchito Zathu Zosintha Mwamakonda Anu

Kusintha Mwaukadaulo Wakuya pa Mulingo Uliwonse

Sitimayika chizindikiro chanu m'bokosi - timapereka uinjiniya weniweni wazinthu kuwonetsetsa kuti mayeso anu a mankhwala a OEM akukumana ndi malamulo amsika, miyezo yazachipatala, ndi zoyembekeza za ogwiritsa ntchito.

Custom Assay & Multi-Drug Panels

Konzani ndendende gulu lomwe msika wanu umafuna - kuphatikiza zowerengera zingapo pachipangizo chimodzi, zofananira ndi zomwe zikuchitika m'madera akuzunza komanso kuletsa malamulo amderalo.

  • Mpaka 18 magawo a mankhwala pa chipangizo chimodzi
  • Magawo odulidwa mwamakonda (SAMHSA, EMCDDA, AS/NZS, bespoke)
  • Mkodzo, malovu (oral fluid), ndi matrices atsitsi
Pemphani Mawu →

Mawonekedwe a Chipangizo & Mapangidwe Athupi

Siyanitsani mtundu wanu ndi mawonekedwe apadera akuthupi. Timapereka mitundu ingapo yanyumba ndipo titha kusintha mawonekedwe ndi mitundu yamitundu kuti igwirizane ndi zomwe mumakonda msika.

  • Ma Strip, Cassette, Dip-Card, kapena Integrated Cup
  • Mitundu yanyumba mwamakonda ndi zolemba zolemba
  • Tamper-zisindikizo zowonekera ndi chigololo-onani kuphatikiza
Pemphani Mawu →

Packaging Private Label

Perekani mtundu wogwirizana kuchokera ku makatoni akunja kupita ku thumba loyesera la munthu aliyense. Gulu lathu la mapulani amkati-anyumba amapanga akatswiri, malamulo-zojambula kuti muvomereze.

  • Mwamakonda-osindikizidwa nayitrogeni-zikwama zotayira
  • Zambiri-zilankhulo za IFU (Malangizo Ogwiritsa Ntchito).
  • Makatoni ogulitsa odziwika ndi kuchuluka kwa zipatala-mabokosi ogulitsa
Pemphani Mawu →

Regulatory Kusunga Thandizo

Kuyendetsa malamulo a zida zachipatala ndizovuta. Timapereka zolemba zonse zaukadaulo komanso upangiri waukadaulo wofunikira kuti mulembetse zachinsinsi-lembetsani malonda a IVD padziko lonse lapansi.

  • Ma dossiers aukadaulo a CE IVDR, FDA, TGA, ndi ANVISA
  • Analytical performance & data study study pafayilo
  • Zikalata Zogulitsa Zaulere (FSC) ndi ISO 13485 docs
Pemphani Mawu →
OEM Product Catalog

Comprehensive IVD Rapid Test Portfolio Ikupezeka kwa OEM

Mitundu yathu ya OEM imatenga gawo lalikulu-magawo omwe amafunidwa padziko lonse lapansi-za-zofufuza za chisamaliro, zonse zopangidwa molingana ndi GMP-maziko ovomerezeka.

Drugs of Abuse — Urine Tests

Mankhwala Osokoneza Bongo - Mayeso a Mkodzo

Single-panel strips to 18-drug integrated cups for work, clinic, and forensic screening.

Mtengo wa THCMtengo COCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2
Funsani Tsopano →
Drugs of Abuse — Oral Fluid

Mankhwala Osokoneza Bongo - Oral Fluid

Mayeso osasokoneza - osasokoneza mseu ndi malo ogwirira ntchito, kuphatikiza DRUID-zida zotsatana ndi njira zogwiritsira ntchito malamulo.

Mtengo wa THCMtengo COCAMP/MAMPOPIZambiri - Gulu
Funsani Tsopano →
Drugs of Abuse — Hair Tests

Mankhwala Osokoneza Bongo - Mayeso a Tsitsi

Zida zowunikira tsitsi zotuluka pambuyo pake zimapereka zenera lodziwikiratu kwa masiku 90 pakuwunika zamalamulo, inshuwaransi, komanso kuwunika ntchito.

90- Mbiri YamasikuZambiri - GuluELISA Cutoffs
Funsani Tsopano →
Infectious Disease Rapid Tests

Matenda Opatsirana Mayesero Ofulumira

CE-kuyesa kwachangu kwa antigen ndi antibody kwa zolembera za matenda opatsirana m'malo azachipatala komanso ammudzi.

HIV 1/2HBsAgFuluwenza A/BCOVID - 19 AgMalungo
Funsani Tsopano →
Pregnancy & Fertility Tests

Mayeso a Mimba ndi Kubereka

High-sensitivity hCG, LH, ndi FSH kuyezetsa kwa ogula ndi misika yazachipatala yokhala ndi zinsinsi zazikulu - zosankha zamalebulo.

hCG StriphCG KasetiLH OvulationKusamba kwa FSH
Funsani Tsopano →
Cardiac & Tumor Markers

Zolemba Zamtima & Chotupa

Point-ya-kuyezetsa kwachangu komanso kochulukira mwachangu pazadzidzidzi zamtima wamtima komanso kuyezetsa kotupa koyambirira.

Troponin IMtengo wa BNPD - DimaPSAAFP
Funsani Tsopano →
Momwe Timagwirira Ntchito

Private Label OEM Kupanga Njira

Wokonzedwa zaka zoposa 15 kuti atengere malonda anu kuchokera pamalingaliro kupita pakupanga malonda mwachangu komanso motetezeka momwe mungathere.

  1. Kukambirana Koyamba & Kusaina kwa NDA

    Timapanga NDA yogwirizana tisanagawidwe za eni ake. Gawo lodziwikiratu lokhazikika limakhudza msika womwe mukufuna, magulu amankhwala, milingo yodula, zomwe amakonda, komanso kuchuluka kwapachaka.

    ⏱ 1-3 Masiku Antchito

  2. Prototype Sampling & Performance Kutsimikizira

    Gulu lathu la R&D limapanga ndikusonkhanitsa zitsanzo zogwira ntchito malinga ndi zomwe mukufuna. Zitsanzo zimatumizidwa kwa inu kuti mukawunikire labu m'nyumba, kutsimikizira kagwiridwe ka ntchito, komanso kuunika koyenera.

    ⏱ 7–21 Masiku Antchito

  3. Kumaliza kwa Artwork & Regulatory Documentation

    Zitsanzo zikavomerezedwa, gulu lathu lopanga zinthu limamaliza zonse zachinsinsi-zolemba zolemba. Panthawi imodzimodziyo, gulu lathu loyang'anira ntchito limapanga Dossier yaukadaulo kuti mulembetse maulamuliro akudera lanu.

    ⏱ 10–15 Masiku Antchito

  4. Kupha Mgwirizano wa OEM & GMP Mass Production

    Ndi zojambulajambula ndi zolembedwa zovomerezeka, timasaina mgwirizano wa OEM. Oda yanu imapangidwa mu GMP-zipinda zoyeretsedwa zokhala ndi mizere yolumikizira makina kuti zitheke mwachangu, mosasinthasintha.

    ⏱ 30–45 Kalendala Masiku

  5. Kutulutsidwa Kwathunthu kwa QC & International Logistics

    Chigawo chilichonse chimakhala ndi batire lathunthu la QC - mtanda-mapanelo obwereza, kukhudzika / kukhazikika, kukhazikika kofulumira, mawonekedwe - Satifiketi Yowunikira isanatulutsidwe. Kenako timagwirizanitsa katundu ku nyumba yanu yosungiramo katundu.

    ⏱ Masiku 5-7 QC + Kutumiza
Kupanga Bwino Kwambiri

GMP-wopanga zida zoyeserera mwachangu

ISO Class 8 (100,000) GMP Cleanrooms

ISO Class 8 (100,000) GMP Zipinda Zoyeretsa

Kuyika kwa membrane, kukonzekera pad, ndi kuphatikiza komaliza kumachitika mkati mokakamizidwa, tinthu tating'ono-kuyang'aniridwa ndi ISO Class 8 zipinda - zopangidwa kuti zithetse kuipitsidwa kulikonse.

Chinyezi cholimba (RH ≤ 20%) ndi zowongolera kutentha zimatsimikizira kukhazikika kwachilengedwe kwa antibody-antigen conjugates, kuwonetsetsa kuti 24-mwezi wa alumali wamoyo pamizere yonse ya OEM.

ISO 8Kalasi ya Cleanroom
RH ≤20%Kuwongolera Chinyezi
24 Mo.Shelf Life
High-Volume Automated Production Lines

High-Volume Automated Production Lines

CNC-makina obowola oyendetsedwa, maloboti-malo olumikizirana othandizira, ndi nayitrogeni wodzipangira - thumba lachikwama-mizere yosindikizira imakwaniritsa zofunikira zapadziko lonse lapansi kwinaku akuchepetsa kusiyanasiyana kochititsidwa ndi anthu - kupeza ma CV otsika mosadukiza m'malo onse.

Kupanga kwathu kumapitilira mayeso omaliza 100,000 patsiku, zomwe zimapangitsa kuti OEM ichuluke nthawi zotsogola za masiku 30 mpaka 45 kuchokera pa siginecha ya mgwirizano.

100K+Mayeso / Tsiku
30–45Nthawi Yotsogolera Tsiku
<5% CVKusasinthika Kwambiri
Regulatory Trust

Ziphaso Zodziwika Padziko Lonse

Malo athu ndi zogulitsa zimakwaniritsa miyezo yolimba kwambiri yapadziko lonse lapansi ya IVD, kupatsa malonda anu a OEM maziko odziwika padziko lonse lapansi, omveka bwino.

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Nkhani Zopambana za Partner

Kukhulupiriridwa ndi IVD Brands Kudutsa Ma Continent Six

Mgwirizano wanthawi yayitali wa OEM ndi makampani azachipatala, ogawa, ndi mabungwe ogula zinthu ndi boma padziko lonse lapansi.

Kusintha kwawo kwa zitsanzo kunali kofulumira kuposa wopanga wina aliyense yemwe tidayesa. Chikho cha 10-chikho chamkodzo chomwe tinapanga-chidapanga tsopano ndi chathu -kugulitsa SKU pamsika wazaumoyo ku Europe.

Their sampling turnaround was faster than any other manufacturer we evaluated. The custom 10-panel urine cup we co-developed is now our top-selling SKU across the European occupational health market.
David L.Mtsogoleri Wogula - IVD Distributor, Germany 🇩🇪

Tinkafunika FDA-zolemba zovomerezeka pazachinsinsi-mzere woyezera mankhwala munthawi yake. Gulu lawo loyang'anira lidapereka zolemba zonse ndikuthandizira kwathunthu kulembetsa kwathu.

We needed FDA-compliant documentation for our entire private-label drug testing line within a tight timeline. Their regulatory team delivered complete dossiers and fully supported our registration process.
Sarah R.VP of Products - Healthcare Brand, USA 🇺🇸

Pambuyo pazaka zitatu za mgwirizano, kusasinthika kwawo kwa kupanga ndi kuyankha kumakhalabe chitsanzo. Timagwiritsa ntchito mayunitsi opitilira mamiliyoni awiri pachaka kudzera m'malo awo popanda kuthawa kwabwino kwambiri.

After three years of partnership, their production consistency and responsiveness remain exemplary. We run over two million units annually through their facility with zero critical quality escapes on record.
Mohammed K.CEO - Diagnostics Company, UAE 🇦🇪
Mafunso Odziwika

OEM Partnership FAQs

Chilichonse chomwe muyenera kudziwa musanayambe ntchito yanu yoyamba ndi ife.

Kodi MOQ ya mayeso a mankhwala a OEM ndi chiyani?

5,000 pcs/SKU pa makaseti ndi akamagwiritsa mizere; 2,000 ma PC kwa Integrated makapu. Zitsanzo zowunikira (mayunitsi 50-200) omwe amapezeka patsogolo pa malonda.

Kodi sampuli za OEM zimatenga nthawi yayitali bwanji?

Zosintha zokhazikika: 7-10 masiku abizinesi. Zolemba zatsopano zomwe zimafuna chitukuko chatsopano cha analyte kapena kudulidwa mwachizolowezi-kuchotsa: masabata 3-6.

Kodi mungathandizire kulembetsa kwazinthu m'dziko lathu?

Inde - Ma Dossiers athunthu aukadaulo a CE IVDR, FDA, TGA, ndi ANVISA, kuphatikiza ma satifiketi a ISO 13485, Declaration of Conformity, ndi Zikalata Zogulitsa Zaulere (FSC).

Kodi mumasayina ma NDA kukambirana zaukadaulo?

Mwamtheradi. Mutual NDA imayendetsedwa musanasinthidwe zambiri za eni ake. Likupezeka mu Chingerezi, Chitchaina, Chisipanishi, ndi Chijeremani.

Kodi nthawi yotsogolera yopanga zinthu zambiri ndi iti?

30-45 masiku a kalendala pambuyo pa kusaina zojambulajambula-kuchotsedwa ndikuchita mgwirizano. Zosankha zofulumira zomwe zilipo - kambiranani nthawi yanu ndi gulu lathu lazamalonda.

Kodi ndingatchule makonda odulidwa -

Inde. Timapanga kukhala SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, kapena kasitomala aliyense-kutchulidwa kudula-kudula. Zonse zimatsimikiziridwa motsutsana ndi zolemba zovomerezeka zisanapangidwe.

Kodi mumakupatsirani zolemba zonse zachinsinsi?

Inde - chizindikiro chanu panyumba ya chipangizocho, thumba lazojambula, makatoni akunja, ndi IFU. Palibe dzina la wopanga pazogulitsa zanu. Mafayilo osinthika omwe amaperekedwa pomaliza ntchito.

Yambanipo Lero

Yambitsani Ntchito Yanu ya OEM / ODM

Gulu lathu limayankha mkati24 maola ntchitondi malingaliro oyambira ndi mitengo yowonetsera.

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Kuti tikupatseni zokumana nazo zabwino kwambiri, timagwiritsa ntchito matekinoloje ngati makeke kusunga ndi/kapena kupeza zidziwitso zapachipangizo. Kuvomereza matekinolojewa kudzatithandiza kukonza zinthu monga kusakatula kapena ma ID apadera patsamba lino. Kusavomereza kapena kuchotsa chilolezo, kungawononge zinthu zina ndi ntchito zina.
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