Onye nrụpụta ngwa ule ngwa ngwa na China - OEM & N'ogbe IVD/POCT Supplier

Ihe mere ndị nrụpụta ji ahọrọ Laihe

Ike nrụpụta isi anọ

Mgbe ihe fọrọ nke nta ka ọ bụrụ afọ iri abụọ na IVD, ndị a bụ ikike ndị mmekọ anyị na-adabere na nrubeisi zuru ụwa ọnụ na nnyefe a pụrụ ịdabere na ya.

1. Smart Mfg

Nrụpụta Smart, Nnyefe ntụkwasị obi

Ọtụtụ ahịrị mmepụta akpaaka zuru oke gafere 9,200㎡ - maka ma fluorescence immunoassay na nyiwe ọla edo colloidal.

Anyị na-ekwe nkwa ezigbo batch-to-nchịkọta ọnụ na ikike zuru oke iji jikwaa nnukwu iwu sitere n'ọtụtụ ahịa na-enweghị nkwekọrịta.

2. njikwa mma

Ọgwụgwụ-ga-Njikwa njikwa mma na njedebe zuru ụwa ọnụ

Usoro njikwa ogo anyị na-ekpuchi ihe niile: nyocha akụrụngwa na-abata, n'ime-nleba anya usoro n'oge ọ bụla, yana ntọhapụ ngwaahịa ikpeazụ yana nzacha nzacha zuru oke.

Asambodo n'okpuruISO 13485, ISO 9001 na MDSAP- ụlọ nyocha QC anyị na-akwado ọkwa ọ bụla na njiri mara na nkwụsi ike nke mba ụwa.

3. Ịkpọnye Chain

Ụyọkọ ụlọ ọrụ na-ebunye Assuranc

N'ịbụ nke dị n'ime ụyọkọ mmepụta ihe IVD tozuru etozu nke Hangzhou, anyị na-enwe mmekọrịta ogologo oge na narị narị ndị na-ebubata akụrụngwa.

Uru abụọ a nke ọdịdị ala na gburugburu ebe obibi pụtara nzaghachi ngwa ngwa maka ọchịchọ ahịa, iwepụta ihe ndị bụ isi na-akwụsi ike, yana oge ndu ekwenyere.

4. Ọkachamara nka

Ọkachamara nka na nka na njikwa usoro

N'ihe fọrọ nke nta ka ọ bụrụ afọ iri abụọ ọkachamara na nyocha ihe mgbochi, njikarịcha usoro, yana mmepụta oke, R&D na ndị otu mmepụta anyị nwere nka na-ebufe usoro tozuru oke.

Usoro ọ bụla na-ahapụ ụlọ nyocha na-emepụta ihe na-enweghị ịchụpụ uche na nkọwapụta nke enwetara n'ogo bench - yana ọnụ ahịa ọnụ ahịa na-eme ka oke gị dị irè.

Pọtụfoliyo ngwaahịa

Kedu ụdị ngwa ule ngwa ngwa
anyị na-arụpụta?

Site na nyocha ọgwụ oge niile ruo n'ihe nrịbama obi pụrụ iche - a na-arụpụta ule ọ bụla n'ahịrị akpaghị aka ma kwado ya megide ụkpụrụ arụmọrụ mba ụwa.

Ngwa nyocha ngwa ngwa ọgwụ ọjọọ

Nnukwu - uche, dị elu-kpọmkwem asọmpi njide immunoassays wuru na teknụzụ Lateral Flow Immunoassay (LFIA) egosipụtara maka ụlọọgwụ, ebe ọrụ, na ebe-nyocha ọgwụ nlekọta. Akwadoro megide ụkpụrụ ụlọ nyocha GC/MS iji wepụta nsonaazụ ziri ezi, nke a pụrụ ịdabere na ya yana obere ihe nlebara anya ụgha.

Dakọtara na ụkpụrụ zuru ụwa ọnụ maka nyocha ọgwụ ọjọọ

Enwere ike ịhazi ọtụtụ - panel (ihe ruru 14-in-1)

Gụọ oge n'okpuru nkeji 5

Omenala mbelata- ọkwa dị maka ndị ahịa OEM

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ngwa nyocha ngwa ngwa ọrịa iku ume

Iji Colloidal Gold Immunochromatographic Assay na Fluorescence Immunoassay teknụzụ, ọrịa iku ume anyị na-anwale ngwa ngwa na-akwado nchọpụta antigen ngwa ngwa maka Influenza A/B, RSV, COVID-19, ADV, HMPV, PIV, na ngalaba nje. Ezubere maka gburugburu ọkachamara nleba anya-nke-nleba anya (POCT), ngalaba mberede ụlọ ọgwụ na mmemme ahụike ọha na-anabata azịza ndị a n'ọtụtụ ebe.

Ogwe ngwakọta maka nchọpụta multiplex n'otu oge

Dakọtara na nasopharyngeal & nasal swab samples

Ụdị CE-IVD kwadoro dị

Ndụ nchekwa ruo ọnwa 36 na 2-30 Celsius

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ngwa nyocha ngwa ngwa ọrịa na-efe efe

Nnukwu Mepụtara ya na nhụsianya dị elu, dị elu- teknụzụ immunochromatographic (colloidal gold) akọwapụtara, emebere maka nleba anya na nyocha ụlọ nyocha ụlọ ọgwụ. A kwadoro ngwaahịa ọ bụla n'ụzọ siri ike megide ụzọ nyocha ụlọ nyocha (dịka, PCR, omenala, ma ọ bụ ELISA) iji hụ na arụpụtaghị ihe ziri ezi, enwere ike imepụtagharị yana obere cross-mmeghachi omume.

Nchọpụta mbụ nke ụdị serotypes Dengue anọ (DEN-1 ruo DEN-4)

ANVISA (Brazil) tụlere

Edebara aha na ewu ewu na ndịda ọwụwa anyanwụ nke mba Eshia

Nsonaazụ n'ime nkeji iri na ise

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ngwa ule tụụrụ ime

Ngwaọrụ enwere ike ịmegharị + Smart APP Single-Jiri ngwa ule ngwa ngwa (Standalone) eriri, cassette, etiti na usoro dijitalụ.

Ultra-nhụta mbido mbụ (10-20 mIU/ml hCG)

Ụdị nkewa, cassette na etiti

OEM zuru ezu/nkeonwe-nkwakọ ngwaahịa dị

CE akara maka EU OTC ahịa

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ngwa nyocha ngwa ngwa obi

Ihe dị elu - mmetụta fluorescence immunoassay panels maka cTnI, NT-proBNP, D-Dimer, CK-MB, na Myoglobin. Emebere ya maka ihe nleba anya-nke- iji nlekọta na nkeji mgbu obi, ngalaba mberede, na ntọala nlekọta ahụike dịpụrụ adịpụ.

Oke oke ≤ 0.1 ng/mL maka mkpebi dị oke mkpa

Nsonaazụ na nkeji 8–15 site na ọbara dum

Reader-dakọtara maka mkpesa ọnụọgụgụ

Clinically kwadoro megide Central laabu ụzọ

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ihe nrịbama etuto ngwa ngwa ngwa ule

Nnwale nyocha ngwa ngwa maka AFP, CEA, PSA, na akara oncology ndị ọzọ - na-enye ohere ịnweta, mmalite - nhazi ihe egwu ogbo na nyocha ahụike obodo yana ntọala oncology ọkachamara.

Fluorescence nke ọnụọgụ & ọkara - ọnụọgụ

Obere ihe nlele (50-100 µl serum/plasma)

Nyocha ngwa ngwa maka mmemme ahụike ọha mmadụ

Otutu - akụkụ ihe nrịbama dị

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ihe nrịbama mkpali ngwa ngwa ngwa ule

Nyocha ngwa ngwa CRP, PCT, na SAA maka nyocha ngwa ngwa dị iche iche nke nje na-efe efe na-efe efe - dị oke mkpa maka mmemme nlekọta ọgwụ nje na sepsis triage na ụlọ ọgwụ na ntọala nlekọta mbụ.

CRP + SAA combo maka nyocha ọrịa zuru oke

PCT maka sepsis na nlekota ICU

Mkpịsị aka-mkpara ọbara dum dakọtara

Nsonaazụ n'ime nkeji iri n'akụkụ akwa

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ngwa ngwa ule ọgwụgwọ anụmanụ

Ụdị dị iche iche-nnwale nchọpụta ngwa ngwa maka anụ ọhịa, anụ ọhịa, na ọrịa anụ ụlọ. Kwesịrị ekwesị maka ụlọ ọgwụ anụmanụ, ụlọ ọgwụ anụmanụ, na mmemme onyunyo ọrịa ugbo nke chọrọ nsonaazụ ubi ngwa ngwa, ntụkwasị obi.

Ogwe osisi canine na feline (Parvovirus, Distemper, FeLV, FIV)

Enweghị oyi-agbụ achọrọ n'oge eji ubi

Omenala OEM labeling maka ndị nkesa ọgwụgwọ anụmanụ

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Ogo na Nzọụkwụ ọ bụla

GMP-Agbaraara 6- Usoro nhazi ngwa ngwa ule IVD nke 6

Dị ka ụlọ ọrụ - onye na-eduzi In Vitro Diagnostic (IVD), mmepụta anyị Lateral Flow Assay (LFA) na-eso usoro a na-achịkwa nke ọma, GMP-nsogbu kwekọrọ. Site na nhazi ngwa ngwa ruo ntọhapụ ikpeazụ, ngwa ule ọ bụla na-enweta nkwado QA/QC siri ike iji kwenye nhụsianya nyocha dị elu, obere batch-to-niche dị iche iche, yana nrubeisi zuru oke n'ụkpụrụ nhazi ụwa.

01

NC Membrane Precision mkpuchi

Iji ihe dị elu - nkenke nkenke na-ekesa membranes Nitrocellulose nke ọma na antigens/ọgwụ mgbochi, na-ewepụta ahịrị ule dị iche na ntụkwasị obi.

02

Nkwadebe conjugate

Mpempe eriri fiberglass na-ejuju nke nwere ọla edo colloidal kachasị mma ma ọ bụ akara fluorescent, na-esote nkwado njupụta anya siri ike iji gbochie ihe adịgboroja.

03

Iru mmiri-Ịkpọ nkụ ejirila

Na-agwọta ihe niile a na-agwọ n'ime ụlọ ihicha pụrụ iche (RH ≤ 20%) iji kpọchie ọrụ ndu protein ma hụ na nkwụsi ike ogologo oge.

04

Mgbakọta & Mbelata nkenke

Na-etinye ihe ndị ahụ na kaadị nkwado nrapado na iji slitters akpaaka emebere ka ebibie ibe ya kpọmkwem obosara millimita (dịka, 3.0mm, 4.0mm).

05

Akpa foil nke izizi

Akara akpaaka nke ibe/kaseti n'otu n'otu n'ime ahụike - obere akpa foil ọkwa n'akụkụ elu-ndị na-eri ihe iji na-ekwe nkwa ndụ nchekwa ọnwa 24.

06

Ikpeazụ QC & Mwepụta

Nlere anya nzacha maka nleba anya na obe-nnwale mmeghachi omume tupu ịkụ ọkpọ akpaaka na akara maka nnabata mbupu zuru ụwa ọnụ.

Laihe Biotech IVD manufacturing facility

0+ Afọ nke IVD
Ọkachamara

Banyere Laihe Biotech

Onye nrụpụta POCT gbanyere mkpọrọgwụ na nkwado sayensị

Laihe Biotech na-emepụta ngwa ngwa nyocha ngwa ngwa na Hangzhou kemgbe 2012. Anyị na-ejikwa yinye mmepụta IVD zuru ezu n'ime-ụlọ - site na nyocha ihe mgbochi na nkwadebe conjugate na mkpuchi akpụkpọ anụ na QC ikpeazụ. Ụdị ogbe anyị-to-nchịkọta ọnụọgụ dị iche iche (CV) bụ ≤ 5%, kwadoro megide usoro nkwenye GC/MS ma ọ bụ LC/MS dabere na nyocha ahụ.

Ụlọ ọrụ GMP 9200

Nkwado usoro iwu EU IVDR

Usoro traceability zuru oke

MOQ sitere na 5,000 pcs

Ndị ọkachamara raara onwe anyị nye

Ọkachamara IVD Multidisciplinary: Injinia Diagnostic Precision

Anyị kwenyere na ụdọ ọkọnọ siri ike na-amalite site n'uche mara mma. N'ịbụ ndị otu ndị ọkachamara karịrị 120+ raara onwe ha nye nkwado, ikike pụrụiche na-akwalite ikike anyị bụ isi. Ndị ọkà mmụta sayensị anyị, ndị injinia biomedical, na ndị nyocha QA na-eweta 15+ afọ nke omimi - ahụmịhe gbanyere mkpọrọgwụ na Lateral Flow Assay (LFA) R&D, usoro reagent, na ọnụ ọgụgụ - nrụpụta elu. Anyị anaghị achịkọta ngwa ule naanị; anyị engineer diagnostic nkenke.

Ụlọ ọrụ GMP 9200 Nkwado usoro iwu EU IVDR Usoro traceability zuru oke MOQ sitere na 5,000 pcs

Otu R&D

Ọpụrụiche na fluorescence immunoassay na colloidal gold nyiwe, ndị ọkà mmụta sayensị anyị jikwaa dum mmepe usoro — si antibody screening ka mmepụta ọnụ ọgụgụ-elu — n'ịhụ ụlọ ọrụ-na-eduga uche, kpọmkwem, na ogbe agbanwe agbanwe.

Otu ihe gbasara iwu

Ọ maara nke ọma na EU IVDR na usoro iwu zuru ụwa ọnụ, ndị otu RA anyị na-enye ahịa ọkachamara - nkwado nnweta - na-enyere ngwaahịa gị aka ịbanye n'ahịa ọhụrụ nke ọma, nke ọma, na-enweghị igbu oge dị oke ọnụ.

Otu ndị ahịa na akwụkwọ

Na-aga nke ọma n'ọtụtụ asụsụ, ndị otu anyị na-ere ahịa na-eme ka nkwurịta okwu enweghị nkebi site na ajụjụ gaa n'usoro. Ọkachamara akwụkwọ anyị na-ejikwa mkpochapụ kọstọm dị mgbagwoju anya maka nnyefe dị larịị oge ọ bụla.

Otu Chain Supply

Dabere na ụyọkọ IVD tozuru okè nke Hangzhou, ndị otu yinye anyị na-arụkọ ọrụ na narị narị ndị na-ebubata ngwaahịa enyochala ma na-achịkwa ntinye ọ bụla - na-ezute ụkpụrụ ịdịmma EU, ngwa ngwa ndịda Ebe Ọwụwa Anyanwụ Eshia - chọrọ ọsọ ọsọ, yana ọnụ ahịa Africa - mkpa ọ dị irè, ha niile nwere oge mbu amụma.

Ọnụnọ zuru ụwa ọnụ

Zute anyị na ihe ngosi IVD International

Dị ka onye nrụpụta IVD mba ụwa, Laihe Biotech na-arụkọ ọrụ na ndị nkesa, ndị mmekọ OEM na ụdị ahụike n'ụwa niile - na-ezute ha ihu na ihu na ihe ngosi ahụike na nchọpụta nyocha n'ofe mba 80+.

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LYHER nwetara nkwado ANVISA maka ngwa nyocha Dengue NS1 Antigen na Brazil!

Anyị enwetala asambodo ngwaahịa ahụ n'aka ANVISA.

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Mụta usoro nnwale ọgwụ mgbochi mmamịrị ozugbo iji kwalite izi ezi, belata mperi yana kwado nnwale na akwụkwọ n'ebe ọrụ.

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