Ikizamini cyihuta cyo gukora ibikoresho mubushinwa - OEM & Ibicuruzwa byinshi IVD / POCT Utanga

Impamvu Ababikora bahitamo Laihe

Imbaraga enye zo gukora

Nyuma yimyaka hafi makumyabiri muri IVD, ubu ni ubushobozi abafatanyabikorwa bacu bahora bashingiraho kugirango isi yubahirizwe kandi itangwe neza.

1. Smart Mfg

Gukora Ubwenge, Gutanga kwizewe

Imirongo myinshi yimikorere yuzuye yakozwe muri 9,200㎡ - kuri fluorescence immunoassay hamwe na zahabu ya colloidal.

Turemeza ko icyiciro cyiza - kugeza - icyiciro gihoraho hamwe nubushobozi buhagije bwo gukemura ibicuruzwa byinshi biva kumasoko menshi nta guhuzagurika.

2. Kugenzura ubuziranenge

Kurangiza - Kuri - Kurangiza Ubuziranenge Kugenzura & Impamyabumenyi Yisi

Sisitemu yacu yo gucunga ubuziranenge ikubiyemo ibintu byose: kugenzura ibikoresho fatizo byinjira, muri - gukurikirana inzira kuri buri cyiciro, no gusohora ibicuruzwa byanyuma hamwe na tombora yuzuye.

Icyemezo munsiISO 13485, ISO 9001, na MDSAP- Laboratoire yacu ya QC yemeza buri cyiciro kugeza ku rwego mpuzamahanga ruyobora ibyiyumvo n'ibipimo bihamye.

3. Gutanga Urunigi

Inganda zinganda & Gutanga Urunigi Assuranc

Turi mu gace ka Hangzhou gakuze gakomeye mu nganda, dukomeza ubufatanye burambye - bw'igihe kirekire hamwe n’ibicuruzwa bitanga ibikoresho by’ibanze bihebuje.

Izi nyungu zibiri za geografiya hamwe nibidukikije bisobanura igisubizo cyihuse kubikenewe ku isoko, isoko ihamye y'ibikoresho by'ibanze, hamwe nigihe cyateganijwe cyo kuyobora.

4. Ubuhanga bwa tekinike

Ubuhanga bwa Tekinike & Gutunganya Ubuhanga

Hamwe nimyaka hafi makumyabiri yinzobere mugupima antibody, gutezimbere inzira, no gupima umusaruro mwinshi, itsinda ryacu R&D hamwe nitsinda ryababyaye bafite ubuhanga bwo kohereza ibintu bikuze.

Inzira zose ziva muri laboratoire zakozwe mu nganda zidatanze ibyiyumvo byihariye kandi byihariye bigerwaho ku gipimo cy'intebe - kandi ku giciro cyiza gikomeza imipaka yawe.

Ibicuruzwa

Ni ubuhe bwoko bwibikoresho byihuta
dukora?

Kuva mugupima ibiyobyabwenge bisanzwe kugeza kumutima wihariye - buri kizamini gikorerwa kumurongo wikora kandi cyemejwe nubuziranenge mpuzamahanga.

Ibiyobyabwenge byo gukoresha nabi ibikoresho byihuse

Ibihe byinshi Byemejwe kurwanya laboratoire ya GC / MS kugirango itange ibisubizo nyabyo, byizewe hamwe nibyiza byibeshya.

Bihujwe nuburinganire bwisi yose kubiyobyabwenge byo gusuzuma nabi

Guhindura byinshi - paneli (kugeza 14 - muri - 1)

Soma inshuro munsi yiminota 5

Gukata ibicuruzwa - guhagarika urwego ruboneka kubakiriya ba OEM

Reba Urwego Rwuzuye

indwara z'ubuhumekero byihuse ibikoresho byo gupima

Twifashishije ikoranabuhanga rya Colloidal Immunochromatographic Assay na Fluorescence Immunoassay, ibizamini byindwara zubuhumekero byihuse bifasha kumenya antigen byihuse kwandura ibicurane A / B, RSV, COVID - 19, ADV, HMPV, PIV, hamwe na co - Byagenewe ingingo yumwuga - ya - ibizamini byitaweho (POCT) ibidukikije, ibi bisubizo bifatwa cyane nishami ryihutirwa ryibitaro na gahunda zubuzima rusange ku isi.

Ikibaho cya combo yo kumenya icyarimwe icyarimwe

Bihujwe na nasopharyngeal & nasal swab sample

CE - Imiterere ihuje na IVD irahari

Ubuzima bwa Shelf kugeza kumezi 36 kuri 2–30 ° C.

Reba Urwego Rwuzuye

indwara zandura byihuse ibikoresho byo gupima

Hejuru - Sensitivity, Hejuru - Umwihariko Immunoassays yo Kwipimisha Indwara Zanduye Kwisi. Yatejwe imbere hamwe - sensibilité, hejuru - yihariye immunochromatografiya (zahabu ya colloidal), yagenewe ingingo yizewe - ya - kwita no gusuzuma laboratoire. Buri gicuruzwa cyemejwe cyane muburyo bwa laboratoire (urugero, PCR, umuco, cyangwa ELISA) kugirango harebwe ibisubizo nyabyo, byororoka hamwe numusaraba muto - reaction.

Kumenya hakiri kare serotypes zose uko ari enye (DEN - 1 kugeza DEN - 4)

ANVISA (Berezile) yasuzumwe

Kwiyandikisha no gukundwa muburasirazuba bwiburasirazuba bwa Aziya

Ibisubizo mu minota 15

Reba Urwego Rwuzuye

ibikoresho byo gupima

Igikoresho gishobora gukoreshwa + Ubwenge bwa APP Bumwe - Koresha Ikizamini Cyihuta Cyibikoresho (Standalone) Strip, cassette, hagati na format ya digitale

Ultra - kwiyumvisha hakiri kare (10–20 mIU / mL hCG)

Imyandikire, cassette, nuburyo bwo hagati

Byuzuye OEM / abikorera - gupakira ibirango birahari

CE yaranze isoko rya EU OTC

Reba Urwego Rwuzuye

Ikimenyetso cyumutima byihuse

Hejuru - sensibilité fluorescence panne immunoassay ya cTnI, NT - proBNP, D - Dimer, CK - MB, na Myoglobin. Yashizweho ku ngingo - ya - gukoresha ubuvuzi mu bice bibabaza mu gatuza, ishami ryihutirwa, hamwe n’ubuvuzi bwa kure.

Umubare ntarengwa ≤ 0.1 ng / mL yo gufata ibyemezo bikomeye

Ibisubizo muminota 8-15 uhereye kumaraso yose

Umusomyi - bihuye na raporo yuzuye

Ivuriro ryemewe kurwanya laboratoire nkuru

Reba Urwego Rwuzuye

ikibyimba cyerekana ibizamini byihuse

Isuzuma ryihuse ryerekana AFP, CEA, PSA, nibindi bimenyetso byingenzi bya onkologiya - bifasha ibyiciro byoroshye, hakiri kare

Umubare wa fluorescence & igice - ingano

Ingano ntoya (50–100 µL serumu / plasma)

Kugenzura byihuse gahunda zubuzima bwabaturage

Multi - marike combo paneli irahari

Reba Urwego Rwuzuye

inflammatory marker yihuta yipimisha

CRP yihuta, PCT, na SAA isuzuma uburyo bwihuse bwo gusuzuma indwara ya bagiteri na virusi zanduye - ingenzi kuri gahunda yo kwita kuri antibiotique hamwe na sepsis triage haba mubitaro ndetse nubuvuzi bwibanze.

CRP + SAA combo yo gusuzuma indwara zuzuye

PCT yo gukurikirana sepsis no gukurikirana ICU

Urutoki - komeza amaraso yose ahuze

Ibisubizo muminota 10 kumuriri

Reba Urwego Rwuzuye

ibikoresho byamatungo byihuse

Ubwoko - ibizamini byihariye byo kwisuzumisha kuri kineine, feline, hamwe nubworozi bwamatungo. Nibyiza kumavuriro yamatungo, ibitaro byinyamanswa, na gahunda yo kugenzura indwara zubuhinzi bisaba ibisubizo byihuse kandi byizewe.

Canine & feline paneli (Parvovirus, Distemper, FeLV, FIV)

Nta bukonje - urunigi rusabwa mugihe cyo gukoresha umurima

Custom OEM labels kubagabuzi b'amatungo

Reba Urwego Rwuzuye

Ubwiza kuri buri Ntambwe

GMP - Yemejwe 6 - Icyiciro IVD Uburyo bwihuse bwo gukora ibikoresho byo gukora ibikoresho

Nka nganda - iyobora Mu ruganda rwa Vitro Diagnostic (IVD), umusaruro wa Lateral Flow Assay (LFA) ukurikiza igenzurwa cyane, GMP - ikurikirana. Kuva mubikoresho fatizo kugeza kumurongo wanyuma, buri kizamini cyikizamini gikora QA / QC kwemeza cyane kugirango byizere ko byisesenguye cyane, icyiciro gito - kugeza - icyiciro gitandukanye, no kubahiriza byuzuye ibipimo ngenderwaho byisi.

01

NC Membrane Yuzuye

Gukoresha murwego rwo hejuru

02

Guhuza Padiri Gutegura

Kwuzuza udupapuro twa fiberglass hamwe na zahabu nziza ya colloidal cyangwa ibimenyetso bya fluorescent, hanyuma bigakurikirwa no kwemeza gukomera kwa optique kugirango wirinde ibyiza.

03

Ubushuhe - Kugenzura Kuma

Gukiza ibikoresho byose byavuwe mubyumba byabugenewe byumye (RH ≤ 20%) kugirango ufunge ibikorwa byibinyabuzima bya poroteyine kandi urebe ko igihe kirekire - gihamye.

04

Guteranya & Gukata neza

Kumurika ibice ku makarita yinyuma yifashisha no gukoresha porogaramu zikoreshejwe zikoreshwa kugirango ugabanye imirongo yubugari bwa milimetero (urugero, 3.0mm, 4.0mm).

05

Amashanyarazi Yibanze

Gufunga byikora kumurongo / cassettes kugiti cye mubuvuzi - icyiciro cya foil pouches hamwe na desiccants zo hejuru kugirango zizere ubuzima bwamezi 24 -

06

QC Yanyuma & Kurekura

Icyitegererezo cyinshi cyo gusesengura ibyiyumvo byisesengura no kwambuka - kugerageza gukora mbere yo guterana amakofe mu buryo bwikora no kuranga ibicuruzwa byoherezwa mu mahanga ku isi.

Laihe Biotech IVD manufacturing facility

0+ Imyaka ya IVD
Ubuhanga

Ibyerekeye Laihe Biotech

URUGENDO RWA POCT rufite imizi mu kwemeza ubumenyi

Laihe Biotech yatangiye gukora ibikoresho byipimisha byihuse muri Hangzhou kuva 2012. Tugenzura urwego rwuzuye rwa IVD mu - inzu - kuva kwipimisha antibody no gutegura conjugate kugeza kuri membrane hamwe na QC yanyuma. Icyiciro cyacu gisanzwe - kugeza - coefficente yo gutandukanya (CV) ni ≤ 5%, byemejwe nuburyo bwa GC / MS cyangwa LC / MS bwo kwemeza bitewe nubushakashatsi.

9200㎡ Amahugurwa ya GMP

Inkunga igenga EU IVDR

Inzira Yuzuye

MOQ kuva 5000 pc

Inzobere zacu

Inzobere zitandukanye IVD Inzobere: Ubuhanga bwo Gusuzuma neza

Twizera ko urunigi rukomeye rutangirana ibitekerezo byiza. Dushyigikiwe nitsinda ryabigenewe ryinzobere zirenga 120+, ubushobozi bwacu bwibanze butwarwa nimpano kabuhariwe. Abashakashatsi Bacu Bakuru, Abashakashatsi ba Biomedical, hamwe nabagenzuzi ba QA bazana imyaka 15+ yimbitse - uburambe bwashinze imizi muri Lateral Flow Assay (LFA) R&D, gukora reagent, hamwe nubunini - kuzamura inganda. Ntabwo dukusanya ibikoresho byo kwipimisha gusa; twe injeniyeri yo gusuzuma neza.

9200㎡ Amahugurwa ya GMP Inkunga igenga EU IVDR Inzira Yuzuye MOQ kuva 5000 pc

Itsinda R&D

Inzobere muri fluorescence immunoassay hamwe na platifike ya zahabu ya colloidal, abahanga bacu bayobora inzira zose ziterambere - kuva kwipimisha antibody kugeza ku musaruro - hejuru - kwemeza inganda - kuyobora ibyiyumvo byihariye, umwihariko, hamwe no guhuza ibice.

Itsinda rishinzwe kugenzura ibikorwa

Nibyiza - uzi neza EU IVDR hamwe nuburyo bugenzurwa nisi yose, itsinda ryacu RA ritanga isoko ryumwuga - inkunga yo kubona - gufasha ibicuruzwa byawe kwinjira mumasoko mashya kubahiriza, neza, kandi nta gutinda bihenze.

Amakipe yo kugurisha & inyandiko

Kumenya indimi nyinshi, itsinda ryacu ryo kugurisha ryemeza itumanaho ridasubirwaho kuva mubushakashatsi kugeza kurutonde. Inzobere zacu zibyangombwa zitanga gasutamo igoye kugirango itangwe neza buri gihe.

Gutanga Urunigi

Dushingiye ku itsinda rya IVD rikuze rya Hangzhou, itsinda ryacu rishinzwe gutanga amasoko rifatanya n’abashoramari babarirwa mu magana kandi rigenzura byimazeyo ibyinjira byose - byujuje ubuziranenge bw’ubumwe bw’ibihugu by’Uburayi, ibyo mu majyepfo y’iburasirazuba bwa Aziya byihuta - byihutirwa, hamwe n’ibiciro bya Afurika -

Kubaho kwisi yose

Mudusange mumurikagurisha mpuzamahanga IVD

Nkumushinga mpuzamahanga wa IVD, Laihe Biotech ikorana nabatanga ibicuruzwa, abafatanyabikorwa ba OEM, hamwe n’ibirango byita ku buzima ku isi - guhura nabo imbonankubone mu imurikagurisha rikomeye ry’ubuvuzi n’isuzuma mu bihugu 80+.

Inyandiko Yerekanwe

Abaterankunga Intsinzi

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

Laihe Biotech Yerekana Kwipimisha BIKORWA BIKORWA BIKORESHWA BIKORESHEJWE NA WHX Bangkok & WHX Labs Bangkok 2026

Itariki: 8 Nyakanga 2026

Soma Inyigisho Case

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

Laihe Biotech kugirango yerekane ibisubizo byibizamini byihuse kuri whx & whx labore (Medlab Asia & Ubuzima bwiza) Maleziya 2025

Itariki: 16 - 18 Nyakanga 2025 Aho biherereye: Maleziya Ikigo mpuzamahanga cy’ubucuruzi n’imurikagurisha (MITEC) Icyumba cy’inzu: S25 Laihe Biotech yishimiye gutangaza ko izitabira WHX Labs Kuala Lumpur 2025, imurikagurisha ryambere ry’ubuzima muri Maleziya.

Soma Inyigisho Case

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

LYHER Yabonye ANVISA Icyemezo cya Dengue NS1 Ikizamini cya Antigen muri Berezile！

Twabonye icyemezo cyibicuruzwa muri ANVISA.

Soma Inyigisho Case

Amakuru agezweho ya sosiyete

Amakuru agezweho ya IVD

Laihe Biotech Yerekana Kwipimisha BIKORWA BIKORWA BIKORESHWA BIKORESHEJWE NA WHX Bangkok & WHX Labs Bangkok 2026

Itariki: 8 Nyakanga 2026

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Instant urine drug test cup step by step guide

Ako kanya ibiyobyabwenge byipimisha igikombe intambwe ku ntambwe

Wige intambwe - by - intambwe yintambwe yo gupima imiti yinkari kugirango wongere ukuri, kugabanya amakosa, no gushyigikira ibizamini byakazi hamwe nibyangombwa.

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Complete Guide to Covid-19 Antibody Testing for Global Buyers

Igitabo Cyuzuye Kuri Covid - 19 Kwipimisha Antibody Kubaguzi Bisi

Wige Covid - 19 ibizamini bya antibody: ubwoko, ubunyangamugayo, ibyemezo, nuburyo bwo kugenzura abatanga ibyiringiro ukoresheje urutonde na OMS - ubuyobozi bushyigikiwe.

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How Covid 19 Walgreens Testing works from booking to results

Nigute Covid 19 Walgreens Ikizamini gikora kuva kubitabo kugeza kubisubizo

Intambwe - by - intambwe yubuyobozi kuri Walgreens Covid kwipimisha: uburyo bwo gutondeka, icyo uzana, nicyo utegereje kuri drive - thru, hamwe na CDC isobanutse - amakuru ashyigikiwe.

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Covid 19 Test Kits Comparative Analysis PCR vs Antigen

Covid 19 Ibikoresho byo Kugereranya Isesengura PCR vs Antigen

Gereranya Covid - 19 PCR vs antigen, wumve neza vs umuvuduko, hanyuma uhitemo ikizamini gikwiye cyurugendo, akazi, cyangwa ibimenyetso ukoresheje OMS - ubuyobozi bushigikiwe.

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Covid 19 Test Free market outlook and trends 2026

Covid 19 Ikizamini cyubusa isoko yubusa hamwe niterambere 2026

Shakisha ubushishozi kuri Covid - 19 igeragezwa ryubusa ku isoko ryubusa muri 2026, harimo inzira zisabwa, ihinduka ryibiciro, abakinnyi bakomeye, na OMS - amakuru ashyigikiwe.

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