- 23
- Jun
I-Omni Sterile Nasopharyngeal PCR TEST Inayiloni Isifanekiso iqoqo Flocked Swab
I-Omni Sterile Nasopharyngeal PCR TEST Inayiloni Isifanekiso iqoqo Flocked Swab
Product Incazelo
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Inombolo Ingxenye
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Ithiphu Ehlanjululwe(mm)
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Ubukhulu Bamba(mm)
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Okufakiwe
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|||||
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ububanzi
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Ubukhulu
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ubude
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Ububanzi 1
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Ububanzi 2
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Ubude be-Breakpoint obunjiwe ukusuka kuThiphu
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Ubude obuphelele
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||
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CY-96000
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3
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3
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16
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2.5
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Qhafaza ku-1.1
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82.5
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150
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100 Swabs/Ibhokisi
50 Amabhokisi/Ikesi |
Umkhiqizi waseShayina ohamba phambili ezintweni ezilahlwayo kwezokwelashwa, Ikhithi Yokuhlola esheshayo ye-CE-IVD nama-reajenti zelabhu, namaphrojekthi wamaseli e-Stem.Ngefektri ye-GMP emibili njenge class 100,000 igumbi elihlanzekile, ikilasi 10,000 lab, ikilasi 100 iyunithi yokukhiqiza nokuningi 29 amalungelo obunikazi abhalisiwe, ukubambisana kocwaningo namanyuvesi asekhaya kanye nelebhu ye-biomedical esezingeni eliphezulu, kancane kancane sigunyazwa yi-CE TGA NMPA ISO13485 MEDL kanye neswab yethu eshicilelwe “Kwemvelo” izikhathi ezi-3 eminyakeni engu-3 edlule. Imikhiqizo yethu eyaziwa emhlabeni wonke ehlanzekile ehlanganisa i-swab, ikhithi ye-VTM, ikhithi yokukhipha i-nucleic acid, ikhithi ye-antigen esheshayo &* ne-antibody test, imaski yobuso ithengiswa ngaphezu kwalokho 129 amazwe, Kubambisane ne-WHO, i-NHS & Mayo clinic,MGI,DDC,Yale University,Cleveland clinic njll.
Ngo-Aug. 2013, CE ukuklonyeliswa,
NgoZibandlela 2014, Ukuphathwa Kwezokudla Nezidakamizwa kwase-US Kusohlwini (njengefekthri yokuqala yase-China yokuswayipha),
Ngo-2016, imboni ye-GMP eneClass 100,000 igumbi elihlanzekile neklasi 10000,Lab,Ikilasi 100 i-workshop eyakhiwe,
Ngo-May 2020, ISO13485 khishiwe,
Ngo-Aug 2020, ngithole E-USA
NgoZibandlela 2014, Ukuphathwa Kwezokudla Nezidakamizwa kwase-US Kusohlwini (njengefekthri yokuqala yase-China yokuswayipha),
Ngo-2016, imboni ye-GMP eneClass 100,000 igumbi elihlanzekile neklasi 10000,Lab,Ikilasi 100 i-workshop eyakhiwe,
Ngo-May 2020, ISO13485 khishiwe,
Ngo-Aug 2020, ngithole E-USA
ukunakekelwa kwezempilo ngawe.
Kuyivelu yethu ewumongo esingakunikeza yona okuthembekile & ephephile umkhiqizo wezokwelapha ukunakekelwa kwempilo yabantu.
Singabahlinzeki bezixazululo zezobuchwepheshe, ithimba lethu linokungaphezu kwalokho 300 abasebenzi
Sicela uthembe wethu imikhiqizo yekhwalithi futhi imisebenzi yobungcweti!
Sibamba iqhaza emibukisweni yezokwelapha echwepheshile nedumile minyaka yonke, njengokuthi Umbukiso weMedica eJalimane, umbukiso weMedlab eDubai kanye neCMEF eChina
Ukupakisha komkhiqizo
Imibuzo Evame Ukubuzwa
Q1: Ingabe uyayisekela i-OEM/ODM? A: YEBO, singakwazi uku-prototype futhi senze ngokwezifiso umkhiqizo ofanele ngokuya ngesicelo sakho esithile. Q2: Ingabe unayo i-GMP Lab? A: YEBO, sinelebhu yethu ye-GMP eyakhiwe ngo-2016. Q3: Ingabe unazo izitifiketi? IMPENDULO: YEBO, sinazo zonke izitifiketi ezidingekayo zokuthekelisa kanye nemvume yasendaweni yesiko. Q4: Unesikhathi esingakanani ukhiqiza izinto ezisetshenziswayo zezokwelapha? A: Isungulwe ngo-2008, ukukhiqizwa kwefekthri yethu, ukuthengisa, ukudiliva isevisi yokuma okukodwa. Q5: Ikuphi imakethe yakho enkulu? A: 60% emazweni aseMelika, 30% emazweni aseYurophu kanye 10% eMpumalanga Ephakathi. Q6: Yisiphi isikhathi sakho sokuhola? A: Ngokukhiqiza ngobuningi, siletha ngamaqoqo futhi iqoqo lokuqala lingalethwa zingakapheli izinsuku eziyi-7. Q7: Ingabe unazo izitifiketi? A: YEBO, sinazo zonke izitifiketi (ISO13485,CE,FSC,TGA,NMPA) ezidingekayo ukuze zithekelise kanye nemvume yasendaweni yesiko.