Umkhiqizi Wekhithi Yokuhlola Esheshayo e-China - I-OEM ne-Wholesale IVD/POCT Supplier

Kungani Abakhiqizi Bakhetha I-Laihe

Amandla Amane Okukhiqiza Abalulekile

Cishe ngemva kweminyaka engamashumi amabili ku-IVD, lawa amandla ozakwethu abathembele kuwo ngokungaguquki ukuze bathole ukuthobelana komhlaba wonke kanye nokulethwa okuthembekile.

1. I-Smart Mfg

Ukukhiqiza Okuhlakaniphile, Ukulethwa Okuthembekile

Imigqa eminingi yokukhiqiza ezenzakalelayo egcwele kuyo yonke i-9,200㎡ - yakho kokubili i-fluorescence immunoassay kanye nezinkundla zegolide ze-colloidal.

Siqinisekisa ukuvumelana okuhle kakhulu kweqoqo-kuya-kunqwabelana namandla owanele okuphatha ama-oda enqwaba ngesikhathi esisodwa avela ezimakethe eziningi ngaphandle kokuyekethisa.

2. Ukulawulwa Kwekhwalithi

Ukuphela-kuya-Ukulawula Ikhwalithi Nokunikezwa Kwezitifiketi Zomhlaba

Isistimu yethu yokuphatha ikhwalithi ihlanganisa yonke into: ukuhlolwa kwempahla eluhlaza engenayo, ukuqapha kwenqubo kuzo zonke izigaba, nokukhishwa komkhiqizo kokugcina okunokulandeleka okugcwele kwenkatho.

Kuqinisekiswe ngaphansiISO 13485, ISO 9001, kanye ne-MDSAP- Ilabhorethri yethu ye-QC iqinisekisa zonke iqoqo kumabhentshimakhi okuzwela nokusimama okuhola emhlabeni jikelele.

3. Supply Chain

I-Industrial Cluster & Supply Chain Assuranc

Sitholakala phakathi kweqoqo lezimboni ze-IVD ezivuthiwe zase-Hangzhou, sigcina ubudlelwano besu besikhathi eside namakhulu abahlinzeki bempahla eluhlaza.

Le nzuzo ekabili yezwe kanye ne-ecosystem isho ukusabela okusheshayo esidingweni semakethe, ukutholakala okuzinzile kwezinto ezibalulekile, nezikhathi zokuhola eziqinisekisiwe.

4. Ubuchwepheshe

Ubungcweti Bobuchwepheshe Nobungcweti Benqubo

Cishe eminyakeni engamashumi amabili esebenza ngokukhethekile ekuhloleni amasosha omzimba, ukuthuthukiswa kwenqubo, nokukala ukukhiqizwa ngobuningi, amaqembu ethu e-R&D kanye namaqembu akhiqiza anolwazi lokudlulisa inqubo evuthiwe.

Yonke ifomula eshiya ilebhu yenziwa ngokwezimboni ngaphandle kokudela ukuzwela nokucaciswa okufinyelelwa esikalini sebhentshi - futhi ngezindleko ezisebenza kahle ezigcina amamajini akho esebenza.

Iphothifoliyo Yomkhiqizo

Yiziphi izinhlobo zamakhithi okuhlola okusheshayo
siyakhiqiza?

Kusukela ekuhlolweni kwezidakamizwa okuvamile kuya komaka benhliziyo abakhethekile - konke ukuhlolwa kukhiqizwa emigqeni yethu ezenzakalelayo futhi kugunyazwe ngokumelene nezindinganiso zokusebenza zamazwe ngamazwe.

Izidakamizwa Zokuhlukumeza Amakhithi Okuhlola Asheshayo

Okuphezulu-okuzwela, okuphezulu-ukuhlola okuqondile okubophayo okubophayo okubophayo okwakhelwe phezu kobuchwepheshe obufakazelwe be-Lateral Flow Immunoassay (LFIA) bomtholampilo, indawo yokusebenza, kanye nephuzu-of-ukuhlolwa kwezidakamizwa zokunakekelwa. Kugunyazwe ngokumelene namazinga aselabhorethri e-GC/MS ukuze kulethwe imiphumela enembile, ethembekile enamaphuzu angamanga ancishisiwe.

Kuqondaniswe nezindinganiso zomhlaba wonke zokuhlolwa kwezidakamizwa zokuhlukunyezwa

Multi-amaphaneli enziwe ngokwezifiso (kufika ku-14-in-1)

Funda izikhathi ezingaphansi kwemizuzu emi-5

Amaleveli okusika-okucisha ayatholakala kumakhasimende e-OEM

Buka Ibanga Eligcwele

Ikhithi yokuhlola ngokushesha isifo sokuphefumula

Sisebenzisa ubuchwepheshe be-Colloidal Gold Immunochromatographic Assay kanye nobuchwepheshe be-Fluorescence Immunoassay, ukuhlola kwethu okusheshayo kwesifo sokuphefumula kusekela ukutholwa kwe-antigen esheshayo ye-Influenza A/B, RSV, COVID-19, ADV, HMPV, PIV, kanye namaphaneli okutheleleka nge-co-infection. Idizayinelwe indawo yobungcweti yephoyinti-of-yokuhlola ukunakekelwa (POCT), lezi zixazululo zamukelwa kabanzi iminyango yezimo eziphuthumayo yasesibhedlela nezinhlelo zezempilo zomphakathi emhlabeni wonke.

Amaphaneli e-Combo okutholwa kanyekanye kwe-multiplex

Ihambisana namasampula e-nasopharyngeal & nasal swab

CE-IVD amafomethi athobelayo ayatholakala

Impilo yeshelufu kufika ezinyangeni ezingama-36 ku-2-30°C

Buka Ibanga Eligcwele

Ikhithi yokuhlola ngokushesha isifo esithathelwanayo

Okuphezulu-Ukuzwela, Okuphezulu-Izivivinyo Eziqondile Zokuzivikela Ezifweni Zokuhlolwa Kwezifo Ezithathelwanayo Zomhlaba Wonke. Ithuthukiswe ngobuchwepheshe okuphezulu-okuzwela, okuphezulu-okucacisiwe kwe-immunochromatographic (igolide eli-colloidal), elidizayinelwe iphuzu elinokwethenjelwa-lokunakekelwa nokuhlolwa kwelebhu yomtholampilo. Umkhiqizo ngamunye uqinisekiswa ngokuqinile ngokumelene nezindlela zaselabhorethri eziyisethenjwa (isb., i-PCR, isiko, noma i-ELISA) ukuze kuqinisekiswe imiphumela enembile, ekwazi ukukhiqizwa futhi enokungqubuzana okuncane-ukuphinda kusebenze.

Ukutholwa kusenesikhathi kwawo wonke ama-serotypes we-Dengue (DEN-1 kuya ku-DEN-4)

I-ANVISA (Brazil) ihloliwe

Ibhalisiwe futhi idumile emazweni aseNingizimu-mpumalanga ye-Asia

Imiphumela emizuzwini eyi-15

Buka Ibanga Eligcwele

ikhithi yokuhlola evundile

Idivayisi Esebenziseka Kabusha + I-Smart APP Eyodwa-Sebenzisa Ikhithi Yokuhlola Esheshayo (Izimele) I-Strip, ikhasethi, i-midstream kanye nefomethi yedijithali

I-Ultra-ukuzwela kokutholwa kusenesikhathi (10–20 mIU/mL hCG)

I-strip, i-cassette, namafomethi aphakathi nendawo

I-OEM egcwele/eyimfihlo-ifakwe ilebula iyatholakala

I-CE imakwe emakethe ye-EU OTC

Buka Ibanga Eligcwele

ikhithi yokuhlola ngokushesha umaka wenhliziyo

Amaphaneli e-High-sensitivity fluorescence immunoassay e-cTnI, NT-proBNP, D-Dimer, CK-MB, ne-Myoglobin. Idizayinelwe ukusetshenziswa kwephoyinti-lokunakekelwa kumayunithi ezinhlungu zesifuba, iminyango yezimo eziphuthumayo, nezilungiselelo zokunakekelwa kwezempilo ezikude.

Umkhawulo wobuningi ≤ 0.1 ng/mL wokwenza izinqumo ezibalulekile

Imiphumela emizuzwini eyi-8-15 egazini lonke

Umfundi-uhambisana nokubika komthamo

Kuqinisekiswe ngokomtholampilo ngokumelene nezindlela zaselabhorethri emaphakathi

Buka Ibanga Eligcwele

ikhithi yokuhlola esheshayo ye-tumor marker

Ukuhlolwa okusheshayo kokuhlolwa kwe-AFP, CEA, PSA, nezinye izimpawu ezibalulekile ze-oncology - okuvumela ukufinyeleleka, kusenesikhathi-isigaba sengozi yokuhlukaniswa kokuhlolwa kwezempilo komphakathi kanye nezilungiselelo ze-oncology ezikhethekile.

I-quantitative fluorescence & semi-quantitative

Ivolumu yesampula ephansi (50–100 µL serum/plasma)

Ukuhlolwa okusheshayo kwezinhlelo zezempilo zabantu

I-Multi-marker combo panel iyatholakala

Buka Ibanga Eligcwele

umaka wokuvuvukala ikhithi yokuhlola esheshayo

Ukuhlolwa okusheshayo kwe-CRP, i-PCT, ne-SAA yokuxilongwa okusheshayo komehluko wezifo ezibangelwa amagciwane ngokumelene negciwane - okubalulekile ezinhlelweni zokuphatha ama-antibiotic kanye nokuhlolwa kwe-sepsis kuzo zombili izilungiselelo zasesibhedlela neziyisisekelo.

Inhlanganisela ye-CRP + SAA yokuhlola ukutheleleka okuphelele

I-PCT yokuqapha i-sepsis ne-ICU

Umunwe-induku yegazi lonke iyahambisana

Imiphumela emizuzwini eyi-10 eceleni kombhede

Buka Ibanga Eligcwele

amakhithi okuhlola ngokushesha odokotela bezilwane

Izinhlobo-izivivinyo zokuxilonga ezisheshayo ze-canine, feline, kanye namagciwane emfuyo. Ilungele imitholampilo yezilwane, izibhedlela zezilwane, kanye nezinhlelo zokugada izifo zezolimo ezidinga imiphumela esheshayo nethembekile yenkambu.

Amaphaneli e-Canine & feline (Parvovirus, Distemper, FeLV, FIV)

Awekho ama-cold-chain adingekayo ngesikhathi sokusetshenziswa kwenkundla

Ilebula ye-OEM yangokwezifiso yabasabalalisi bezilwane

Buka Ibanga Eligcwele

Ikhwalithi kuzo Zonke Izinyathelo

I-GMP-Certified 6-Stage IVD Rapid Test Kit Manufacturing Process

Njengomkhiqizi-ohamba phambili we-In Vitro Diagnostic (IVD), ukukhiqizwa kwethu kwe-Lateral Flow Assay (LFA) kulandela okulawulwa ngokuqinile, i-GMP-kulandelana okuthobelayo. Kusukela ekwakhiweni kwezinto ezingavuthiwe kuya ekukhishweni kokugcina kwenkatho, yonke ikhithi yokuhlola ithola ukuqinisekiswa okuqinile kwe-QA/QC ukuze kuqinisekiswe ukuzwela okuphezulu kokuhlaziya, ukuhluka okuncane kwenqwaba-kuya-ku-batch, nokuthobela ngokugcwele izindinganiso zokulawula zomhlaba.

01

I-NC Membrane Precision Coating

Kusetshenziswa izikhiqizo eziphakeme-ezinembayo ukuze kugqokiswe ngokulinganayo ulwelwesi lwe-Nitrocellulose ngama-antigen/amasosha omzimba ahlanzekile, kusungula imigqa yokuhlola ehlukile nethembekile.

02

Conjugate Pad Ukulungiselela

Amaphedi e-fiberglass asuthisayo anegolide le-colloidal elithuthukisiwe noma omaka be-fluorescent, okulandelwa ukuqinisekiswa kwe-optical density okuqinile ukuze kuvinjwe izinto ezingamanga.

03

Umswakamo-Ukomisa Okulawulwayo

Ukwelapha zonke izinto ezilashwayo emakamelweni okomisa akhethekile (RH ≤ 20%) ukukhiya umsebenzi webhayoloji wamaprotheni nokuqinisekisa-uzinzo lwesikhathi eside.

04

Ukuhlanganisa & Ukusika Okunembile

Izingxenye zokunyibilikisa emakhadini asekelayo okunamathelayo nokusebenzisa ama-slitter ahleliwe azenzakalelayo ukusika imicu ibe ngububanzi obuyimilimitha obuqondile (isb., 3.0mm, 4.0mm).

05

I-Primary Foil Pouching

Ukuvalwa okuzenzakalelayo kwemicu/amakhasethi ephaketheni le-medical-grade foil eduze kwama-desiccant aphezulu-amunca ukuze kuqinisekiswe impilo yeshelufu yezinyanga ezingama-24.

06

I-QC yokugcina nokukhishwa

Isampula yenkatho engahleliwe yokuzwela kokuhlaziya kanye nokuhlolwa kokusebenza kabusha ngaphambi kwesibhakela esizenzakalelayo nokulebula ukuze kuthotshelwe ukuthekeliswa komhlaba wonke.

Laihe Biotech IVD manufacturing facility

0+ Iminyaka ye-IVD
Uchwepheshe

Mayelana ne-Laihe Biotech

Umkhiqizi we-POCT Ogxile Ekuqinisekisweni Kwesayensi

I-Laihe Biotech ibikhiqiza amakhithi okuhlola ama-diagnostic asheshayo e-Hangzhou kusukela ngo-2012. Silawula uchungechunge lokukhiqiza lwe-IVD olugcwele - endlini - kusukela ekuhlolweni kwe-antibody kanye nokulungiswa kwe-conjugate kuya ekuhlanganisweni kolwelwesi kanye ne-QC yokugcina. Iqoqo lethu elijwayelekile le-batch-to-batch coefficient of variation (CV) lingu-≤ 5%, ligunyazwe ngokumelene nezindlela zokuqinisekisa ze-GC/MS noma ze-LC/MS kuye ngokuhlolwa.

9200㎡ GMP Workshop

I-EU IVDR Regulatory Support

Ukulandelelwa Kwenqubo Egcwele

I-MOQ isuka ku-5,000 ama-pcs

Ochwepheshe Bethu Abazinikele

Ochwepheshe be-IVD be-Multidisciplinary: Engineering Diagnostic Precision

Sikholelwa ukuthi uchungechunge lokunikezela oluqinile luqala ngezingqondo ezihlakaniphile. Sisekelwa ithimba elizinikele lochwepheshe abangaphezu kuka-120+, ikhono lethu eliyinhloko liqhutshwa ithalente elikhethekile. Ososayensi bethu abakhulu, onjiniyela be-Biomedical, kanye nabahloli be-QA baletha iminyaka engu-15+ yolwazi olujulile-olugxilile ku-Lateral Flow Assay (LFA) R&D, ukwakhiwa kwe-reagent, kanye nokukhiqizwa kwesikali. Asivele sihlanganise izinto zokuhlola; sinjiniyela ukunemba kokuxilonga.

9200㎡ GMP Workshop I-EU IVDR Regulatory Support Ukulandelelwa Kwenqubo Egcwele I-MOQ isuka ku-5,000 ama-pcs

Ithimba le-R&D

Ngokukhethekile nge-fluorescence immunoassay kanye nezinkundla zegolide ze-colloidal, ososayensi bethu baphatha yonke inqubo yentuthuko - kusukela ekuhlolweni kwe-antibody kuya esikalini sokukhiqiza-phezulu - uqinisekisa imboni-kuzwela okuholayo, ukucaciswa, kanye nokuvumelana kwenqwaba.

Ithimba Lezindaba Zokulawula

Izazi - Izazi ze-EU IVDR kanye nezinhlaka zokulawula zomhlaba wonke, ithimba lethu le-RA lihlinzeka ngemakethe yobungcweti-ngosekelo lokufinyelela - lisiza imikhiqizo yakho ukuthi ingene ezimakethe ezintsha ngokuthobelana, ngempumelelo, futhi ngaphandle kokubambezeleka okubizayo.

Amaqembu Okuthengisa Nemibhalo

Ngokushelelayo ngezilimi eziningi, ithimba lethu labadayisi liqinisekisa ukuxhumana okungenazihibe kusukela ekubuzweni kuye eku-odeni. Ochwepheshe bethu bamadokhumenti baphatha imvume eyinkimbinkimbi yamasiko ukuze ilethwe kahle ngaso sonke isikhathi.

Ithimba le-Supply Chain

Ngokusekelwe kuqoqo le-IVD elivuthiwe lase-Hangzhou, ithimba lethu lochungechunge lokuhlinzekwa kwempahla lisebenzisana namakhulukhulu abahlinzeki abahloliwe futhi lilawula ngokuqinile konke okufakwayo - ukuhlangabezana nezindinganiso zekhwalithi ze-EU, izimfuno ezisheshayo-ezisheshayo zaseNingizimu-mpumalanga ye-Asia, kanye nezimfuneko zezindleko-ezisebenzayo zase-Afrika, konke okunezikhathi zokuhola ezingabikezelwa.

Ubukhona Bomhlaba

Hlangana Nathi Emibukisweni Yamazwe Ngamazwe Ye-IVD

Njengomkhiqizi we-IVD wamazwe ngamazwe, i-Laihe Biotech ibambisana nabasabalalisi, abalingani be-OEM, nemikhiqizo yokunakekelwa kwezempilo emhlabeni wonke - ihlangana nabo ubuso nobuso emibukisweni ehamba phambili yezokwelapha neyokuxilongwa emazweni angu-80+.

Irekhodi le-Track eliqinisekisiwe

Amacala empumelelo yokusabalalisa

Laihe Biotech to Showcase Advanced DOA Testing and Hair Drug Testing Solutions at WHX Bangkok & WHX Labs Bangkok 2026

I-Laihe Biotech izobonisa Izisombululo Zokuhlolwa Okuthuthukisiwe kwe-DOA kanye Nezixazululo Zokuhlola Izidakamizwa Zezinwele e-WHX Bangkok & WHX Labs Bangkok 2026

Usuku:Julayi 8-10, 2026Indawo:I-Queen Sirikit National Convention Centre, Bangkok, ThailandInombolo yeBooth:H64 Laihe Biotechis ijabule ukumemezela ukubamba iqhaza kwayo ku-WHX Bangkok & WHX Labs Bangkok 2026, omunye wemibukiso ehamba phambili eNingizimu-mpumalanga ye-Asia yelabhorethri

Funda I-Case Study ➔

Laihe Biotech to Showcase Rapid Test Solutions at WHX&WHX Labs (Medlab Asia&Asia Health) Malaysia 2025

I-LAIHE BITECH ukukhombisa izixazululo ezisheshayo zokuhlola ezivela ku-WHX & WHX Labs (Medlab Asia & Eshiya Health) Malaysia 2025

Usuku: 16-18 July 2025 Indawo: I-Malaysia International Trade and Exhibition Centre (MITEC) Inombolo yeBooth: S25 Laihe Biotech ijabule kakhulu ukumemezela ukubamba iqhaza ku-WHX Labs Kuala Lumpur 2025, umbukiso wokunakekelwa kwezempilo ophambili e-Malaysia.

Funda I-Case Study ➔

LYHER Obtained ANVISA Approval for Dengue NS1 Antigen Test Kit in Brazil！

U-LYHER Uthole Imvume Ye-ANVISA Yekhithi Yokuhlola I-Dengue NS1 Antigen e-Brazil!

Sithole isitifiketi somkhiqizo kwa-ANVISA.

Funda I-Case Study ➔

Izibuyekezo zenkampani

Izindaba zakamuva ze-IVD

I-Laihe Biotech izobonisa Izisombululo Zokuhlolwa Okuthuthukisiwe kwe-DOA kanye Nezixazululo Zokuhlola Izidakamizwa Zezinwele e-WHX Bangkok & WHX Labs Bangkok 2026

Usuku:Julayi 8-10, 2026Indawo:I-Queen Sirikit National Convention Centre, Bangkok, ThailandInombolo yeBooth:H64 Laihe Biotechis ijabule ukumemezela ukubamba iqhaza kwayo ku-WHX Bangkok & WHX Labs Bangkok 2026, omunye wemibukiso ehamba phambili eNingizimu-mpumalanga ye-Asia yelabhorethri

Buka Imininingwane ➔

Instant urine drug test cup step by step guide

Inkomishi yokuhlola umuthi osheshayo wesinyathelo ngesinyathelo

Funda isinyathelo-by-step izinqubo zokuhlola izidakamizwa ezisheshayo zomchamo ukuze uthuthukise ukunemba, unciphise amaphutha, futhi usekele ukuhlolwa okuvumelanayo kwendawo yokusebenza kanye nemibhalo.

Buka Imininingwane ➔

Complete Guide to Covid-19 Antibody Testing for Global Buyers

Umhlahlandlela ophelele we-Covid-19 Antibody Testing for Global Buyers

Funda uhlolo lwe-Covid-19 antibody: izinhlobo, ukunemba, izitifiketi, kanye nendlela yokuqinisekisa abahlinzeki abathembekile usebenzisa izinhlu zokuhlola kanye neziqondiso ezisekelwe yi-WHO.

Buka Imininingwane ➔

How Covid 19 Walgreens Testing works from booking to results

Indlela Ukuhlolwa kwe-Covid 19 Walgreens kusebenza ngayo kusukela ekubhukheni kuya emiphumeleni

Isinyathelo-by-isinyathelo sokuhlola i-Walgreens Covid: ubhukha kanjani, uzoletha ini, nokuthi yini ongayilindela ku-drive-thru, nge-CDC ecacile-imininingwane esekelwe.

Buka Imininingwane ➔

I-Covid 19 Test Kits Comparative Analysis PCR vs Antigen

Qhathanisa i-Covid-19 PCR vs ukuhlolwa kwe-antigen, qonda ukunemba uma iqhathaniswa nesivinini, futhi ukhethe ukuhlolwa okulungile kohambo, umsebenzi, noma izimpawu usebenzisa isiqondiso esisekelwe yi-WHO.

Buka Imininingwane ➔

Covid 19 Test Free market outlook and trends 2026

I-Covid 19 Test Ukubukeka kwemakethe yamahhala kanye nezitayela zango-2026

Thola imininingwane ecacile ngombono wemakethe yamahhala ye-Covid-19 ka-2026, okuhlanganisa amathrendi afunwayo, izinguquko zentengo, abadlali ababalulekile, kanye nedatha esekelwe yi-WHO.

Buka Imininingwane ➔