Indwara Zandura Byihuta Ikizamini - OEM Isuzuma Ryakozwe

Ibicuruzwa

Indwara Yanduye Yihuta Ikizamini & Multiplex Range

Kuva kuri kaseti imwe yindwara kugeza kwandura indwara yanduye multiplex yihuta yipimisha, muri zahabu ya colloidal kuruhande - imiterere yimiterere ya clinique nu murima - wo -

Toxoplasma gondii antibody(Tg Ab) test in serum,plasma and whole blood

Dengue IgG / IgM Igikoresho Cyihuta Cyipimisha (Amaraso Yuzuye / Serumu / Plasma)

IntegoDengue IgG / IgM

IcyitegererezoAmaraso Yuzuye / Serumu / Plasma

CE IVDR ISO 13485

Human Immunodeficiency Virus Test Device

Igikoresho cyo Kwipimisha Immunodeficiency Yumuntu

IntegoVirusi ya Immunodeficiency ya muntu (VIH) ubwoko bwa 1 na / cyangwa ubwoko bwa 2

Icyitegererezomaraso yose, serumu cyangwa plasma

CE IVDR ISO 13485

ToRCH Rubella/CMV/Toxo/HSV IgG Combo Rapid Test Device (Serum/Plasma)

ToRCH Rubella / CMV / Toxo / HSV IgG Combo Igikoresho cyihuta (Serum / Plasma)

IntegoTORCH Rubella / CMV / Toxo / HSV IgG

IcyitegererezoSerumu / Plasma

CE IVDR ISO 13485

Tuberculosis IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

Igituntu IgG / IgM Igikoresho Cyipimisha Byihuse (Amaraso Yuzuye / Serumu / Plasma)

IntegoIgituntu IgG / IgM

IcyitegererezoAmaraso Yuzuye / Serumu / Plasma

CE IVDR ISO 13485

HCV Hepatitis C Ikizamini cya virusi

IntegoVirusi ya Hepatite C.

IcyitegererezoAmaraso Yuzuye / Serumu / Plasma

CE IVDR ISO 13485

VIH 1/2/ O Ikizamini cyihuse

IntegoVIH 1/2 1/2 O virusi ya immunodeficiency ya muntu

IcyitegererezoAmaraso yose / Serumu / Plasma

CE IVDR ISO 13485

28 Bose hamwe

Ibyerekeye Uru Rwego

Ni izihe ndwara zandura Ibizamini Byihuse?

Igikoresho cyihuta cyo gusuzuma indwara cyanduye kimenya antigene ya patogene cyangwa yakira antibodiyide ukoresheje kuruhande - flux immunochromatography, itanga ibisubizo muminota idafite laboratoire nkuru. Ingamba zo gutahura ziterwa nindwara nigihe: antigen ya dengue NS1 igaragara hakiri kare kwandura mugihe IgM / IgG igaragara nyuma; H. pylori irashobora gutahurwa na stool antigen cyangwa antibody antibody; sifilis ikoresha antibody ya treponemal; ibizamini bya malariya bitandukanya ubwoko bwa Plasmodium (P. falciparum, P. vivax, Pan).

Igipfukisho c'indwara

Ikizamini cya Dengue Yihuta Yihuta, Malariya Yihuta Yipimisha Ikizamini, Ikizamini cyihuta cya Syphilis, Ikizamini cyihuta cya H. pylori, Ikizamini cyihuta cya Hepatite B, Ikizamini cyihuta cya Tifoyide - hiyongereyeho imyanya y'ubuhumekero na STI.

Imiterere

Intambwe imwe yindwara yandura yihuta yipimisha cassettes na strip, imwe - indwara hamwe na multiplex combo imiterere, kumaraso yose, serumu, plasma cyangwa intebe bitewe nubushakashatsi.

Uburyo

Colloidal zahabu kuruhande - itemba immunochromatografiya yihuta, igikoresho - ibisubizo byujuje ubuziranenge mubuvuzi n'umutungo -

Ubuyobozi bwa Tekinike

Indwara zandura zisanzwe Uburyo bwihuse bwo Kwipimisha

Ingingo - ya - kwita kuri protocole yo gukoresha umwuga. Buri gihe ukurikire IFU yubushakashatsi bwihariye; ibisubizo bifatika bisaba kwipimisha byemeza.

Kusanya Icyitegererezo

Kusanya icyitegererezo cyagenwe - amaraso yose, serumu / plasma, cyangwa intebe - kuri kit IFU.

Tegura Icyitegererezo

Hindura ingano yagenwe muri buffer / diluent nkuko byasobanuwe muri IFU.

Saba Cassette

Ongeraho umubare wibitonyanga byerekanwe kurugero rwiza (S) rwa cassette yikizamini.

Soma & Emeza

Soma muri idirishya rya IFU. Sobanura imirongo ya C / T kuri IFU hanyuma wohereze ibisubizo bifatika byo gupima ibyemeza no kwa muganga gukurikira - hejuru.

Ikoranabuhanga

Ihuriro rya Zahabu Zahabu - Ikoranabuhanga

Ibizamini byindwara byanduye bikoresha zahabu ya colloidal kuruhande - flux immunochromatography - ingingo yemejwe - ya - urubuga rwo kwita kuri antigen na antibody. Ifasha byihuse, ibikoresho - ibisubizo byubusa bikwiranye n’amavuriro, igisubizo cyibisubizo hamwe numutungo - igenamigambi rito, aho ibyemezo byihuse hamwe no kwigunga ari ngombwa.

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Ibisubizo Byihuse

Ibisubizo bifatika byo kwisuzumisha muminota 10 - 15, ingenzi kuri ER n'amavuriro.

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Kumva neza

Yakozwe muburyo bwo gusesengura ibintu byinshi muburyo busanzwe bwa virusi.

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Ihinduka ryiza cyane

24 - ukwezi kuramba hamwe nibikorwa bihoraho mubushyuhe bwicyumba (2 - 30 ° C).

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Ibisobanuro bigaragara

Byoroshye - to - gusoma imirongo yamabara ikuraho ibikenerwa ibikoresho bihenze.

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Igikorwa cyoroshye

Imwe - intambwe ikurikira itembera protocole, itunganijwe kubintu - bya - ibidukikije byitaweho.

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Umusaruro rusange

Imirongo ikora yimashini itanga ubwinshi bwogutanga isi yose.

Kubahiriza amabwiriza

Impamyabumenyi & Ibyemezo byemewe

Ibikoresho byubuhumekero byubuhumekero bikozwe muburyo bwemewe bwo gucunga neza kandi bigasukurwa ku masoko akomeye ku isi.

Icyemezo cya ISO 13485

Icyemezo cya ISO 9001

Icyemezo cya MDSAP

Burezili ANVISA BGMP

Koresha Imanza

Indwara Zandura Zikoreshwa Ibizamini Byihuse?

Yashizweho kugirango ashyigikire protocole yo kurwanya indwara mu nzego zose z’ibikorwa remezo byubuzima.

Amavuriro & Ibitaro

Inzira yihuse, kwigunga no gufata ibyemezo kubarwayi ba febrile cyangwa ibimenyetso.

Ubuzima Rusange & Icyorezo Igisubizo

Kwipimisha mu murima mugihe cya dengue, malariya cyangwa ibindi byorezo byo kugenzura no kwirinda.

Urugendo & Ubuvuzi bushyuha

Ikizamini cyihuse cyindwara zo mu turere dushyuha gishyigikira isuzuma ryabagenzi batahutse hamwe nisuzuma ryamavuriro.

Abatanga & OEM Ibirango

Indwara yibiranga - intera yihariye kumiyoboro yubuvuzi na gahunda kwisi yose.

Inkunga & Serivisi

Ibibazo Bikunze Kubazwa & Ibisubizo

Ni izihe ndwara indwara zandura zipimisha vuba?

Uru rutonde rurimo dengue, malariya, sifilis, H. pylori, hepatite B, tifoyide, indwara zandurira mu myanya y'ubuhumekero n'indwara zandurira mu mibonano mpuzabitsina, mu buryo bumwe - indwara n'imiterere myinshi. Buriwese ni infashanyo yo gusuzuma ivuriro.

Ikizamini cyihuse gishobora gusuzuma cyangwa kwirinda ubwandu bwonyine?

Oya. Igisubizo cyiza cyangwa cyiza gisaba kwemezwa nuburyo bukwiye bwo gukoreshwa, kandi ibisubizo bibi ntibikuraho kwandura - urugero mugihe cyidirishya. Isuzuma rigomba gukorwa numuvuzi ukoresheje ishusho yuzuye yubuvuzi.

Nshobora gukoresha kuri - murugo STD cyangwa virusi itera sida kugirango menye uko meze?

Urugo rwihuta ibisubizo ni intangiriro gusa. Igisubizo gifatika kigomba kwemezwa no kwipimisha muri laboratoire, kandi ibisubizo byose bigomba kuganirwaho ninzobere mu buzima bushobora gutanga ibizamini byemeza, ubujyanama hamwe n’ubuvuzi. Ntukishingikirize kumuntu umwe - ikizamini kubisubizo byuzuye.

Ubuzima bwo kubika nububiko bumeze bute?

Mubisanzwe amezi 24 uhereye kubikorwa, bibitswe bifunze kuri 2-30 ° C. Emeza ibicuruzwa byihariye IFU.

Indwara zanduza

Umufatanyabikorwa hamwe n’uruganda rwa IVD rwihagaritse mu Bushinwa kubikoresho byo gupima indwara zanduza byinshi. Dutanga iherezo - kugirango - kurangiza kwihindura - dengue NS1 / IgM / IgG, malariya Pf / Pv / Pan, sifilis, H. pylori nibindi byinshi muburyo bwa zahabu ya colloidal, hamwe nibipfunyika byanditseho kandi byinshi - ururimi IFUs - kubakwirakwiza na gahunda rusange zubuzima -

Ikoreshwa rya Multiplex Panel

Huza ibipimo byihariye (urugero, SARS - CoV - 2 + ibicurane A / B + RSV + ADV) muri kimwe 3 - muri - 1, 4 - muri - 1, cyangwa 5 - muri - 1 cassette yikizamini ukurikije ibyifuzo byawe byo mu karere.

Ikirango cyihariye & Gupakira

Serivise yuzuye yubukorikori bwa pouches, byinshi - ururimi IFU yinjiza (Amabwiriza yo Gukoresha), hamwe namakarito yo kugurisha yo hanze ajyanye nibiranga ikirango cyawe.

Inkunga yo Gutanga Amabwiriza

Dutanga ibyangombwa bya tekiniki byuzuye, ubushakashatsi bwo kwemeza imikorere, hamwe namakuru yubuvuzi kugirango twihutishe Minisiteri yubuzima y’ibanze cyangwa CE IVDR kwiyandikisha.

Menyesha

Witegure Inkomoko Yizewe
Ibikoresho byo Kwandura Indwara?

Cataloge itondekanya, OEM multiplex yihariye, cyangwa kugisha inama amabwiriza - itsinda ryacu ryo kugurisha ryishura imbereAmasaha 24ku minsi y'akazi hamwe n'amagambo yatanzwe.

Amapaki yubusa NDA kubisabwe Subiza mu masaha 24