Dekun igbeyewo Apo olupese ni China - OEM & Osunwon IVD / POCT Olupese

Kini idi ti Awọn aṣelọpọ Yan Laihe

Mẹrin Core Manufacturing Agbara

Lẹhin ti o fẹrẹ to ọdun meji ni IVD, iwọnyi ni awọn agbara awọn alabaṣiṣẹpọ wa nigbagbogbo gbarale fun ibamu agbaye ati ifijiṣẹ igbẹkẹle.

1. Smart Mfg

Smart Manufacturing, Gbẹkẹle Ifijiṣẹ

Pupọ awọn laini iṣelọpọ adaṣe adaṣe ni kikun kọja 9,200㎡ - fun ajẹsara fluorescence mejeeji ati awọn iru ẹrọ goolu colloidal.

A ṣe iṣeduro ipele to dara julọ-si-iduroṣinṣin ipele ati agbara ti o to lati mu awọn aṣẹ olopobobo nigbakanna lati awọn ọja lọpọlọpọ laisi adehun.

2. Iṣakoso didara

Ipari-si-Iṣakoso Didara Ipari & Awọn iwe-ẹri Agbaye

Eto iṣakoso didara wa ni wiwa ohun gbogbo: ṣiṣayẹwo ohun elo aise ti nwọle, ni - abojuto ilana ni gbogbo ipele, ati idasilẹ ọja ikẹhin pẹlu wiwa kakiri ni kikun.

Ifọwọsi labẹISO 13485, ISO 9001, ati MDSAP- yàrá QC wa fọwọsi gbogbo ipele si ifamọ ti kariaye ati awọn ipilẹ iduroṣinṣin.

3. Ipese Pq

Iṣupọ Iṣẹ & Ipese Pq Assurac

Ti o wa laarin iṣupọ ile-iṣẹ IVD ti ogbo ti Hangzhou, a ṣetọju pipẹ - awọn ajọṣepọ ilana igba pipẹ pẹlu awọn ọgọọgọrun ti awọn olupese ohun elo aise.

Anfani meji yii ti ẹkọ-aye ati ilolupo tumọ si idahun yiyara si ibeere ọja, orisun iduroṣinṣin ti awọn ohun elo mojuto, ati awọn akoko idari idaniloju.

4. Imọ ĭrìrĭ

Imọ-ẹrọ Imọ-ẹrọ & Ilana Ilana

Pẹlu o fẹrẹ to ewadun meji ti o ni amọja ni ibojuwo antibody, iṣapeye ilana, ati igbejade iṣelọpọ ibi-pupọ, R&D ati awọn ẹgbẹ iṣelọpọ ni oye gbigbe ilana ti ogbo.

Gbogbo agbekalẹ ti o fi laabu silẹ jẹ iṣelọpọ laisi rubọ ifamọ ati pato ti o waye ni iwọn ibujoko - ati ni ṣiṣe idiyele ti o jẹ ki awọn ala rẹ le ṣee ṣe.

Ọja Portfolio

Kini iru awọn ohun elo idanwo iyara
a ṣe iṣelọpọ?

Lati ibojuwo oogun deede si awọn ami ami ọkan pataki - gbogbo idanwo ni a ṣelọpọ lori awọn laini adaṣe wa ati ifọwọsi ni ilodi si awọn iṣedede iṣẹ ṣiṣe kariaye.

Oògùn Of Abuse Dekun igbeyewo irin ise

Ga - ifamọ, giga - ifigagbaga ni pato awọn ajẹsara ajẹsara ti o ni ibatan ti a ṣe lori imọ-ẹrọ Lateral Flow Immunoassay (LFIA) ti a fihan fun ile-iwosan, ibi iṣẹ, ati aaye-ti-ṣayẹwo oogun itọju. Ifọwọsi lodi si awọn iṣedede yàrá GC/MS lati fi deede, awọn abajade igbẹkẹle han pẹlu awọn idaniloju iro ti o dinku.

Ni ibamu pẹlu awọn iṣedede agbaye fun awọn oogun ti iṣayẹwo ilokulo

Awọn panẹli pupọ ti a ṣe asefara (to 14-in-1)

Ka awọn akoko labẹ awọn iṣẹju 5

Aṣa gige - awọn ipele pipa wa fun awọn alabara OEM

Wo Ibiti kikun

ti atẹgun arun ohun elo idanwo iyara

Lilo Colloidal Gold Immunochromatographic Assay ati Fluorescence Immunoassay awọn imọ-ẹrọ, awọn idanwo iyara ti aarun atẹgun wa ṣe atilẹyin wiwa antijeni iyara fun Aarun ayọkẹlẹ A/B, RSV, COVID-19, ADV, HMPV, PIV, ati awọn panẹli akoran. Ti a ṣe apẹrẹ fun aaye ọjọgbọn-ti-awọn agbegbe idanwo itọju (POCT), awọn ojutu wọnyi jẹ itẹwọgba lọpọlọpọ nipasẹ awọn apa pajawiri ile-iwosan ati awọn eto ilera gbogbo agbaye.

Konbo paneli fun igbakana multiplex erin

Ni ibamu pẹlu nasopharyngeal & awọn ayẹwo swab imu

CE-Awọn ọna kika ibamu IVD wa

Igbesi aye selifu titi di oṣu 36 ni 2-30 ° C

Wo Ibiti kikun

àkóràn ohun elo idanwo iyara

Giga - Ifamọ, Giga - Awọn ajẹsara ajẹsara pato fun Ṣiṣayẹwo Arun Irun Kariaye. Idagbasoke pẹlu ifamọra, giga - imọ ẹrọ imunochromatographic (kolloidal goolu) pato, ti a ṣe apẹrẹ fun aaye igbẹkẹle-ti-itọju ati iṣayẹwo ile-iwosan. Ọja kọọkan jẹ ifọwọsi ni lile lodi si awọn ọna ile-itọkasi (fun apẹẹrẹ, PCR, asa, tabi ELISA) lati rii daju pe o peye, awọn abajade atunṣe pẹlu agbelebu kekere -

Wiwa ni kutukutu ti gbogbo awọn serotypes Dengue mẹrin (DEN-1 si DEN-4)

ANVISA (Brazil) ṣe iṣiro

Ti forukọsilẹ ati olokiki ni Guusu ila oorun ti awọn orilẹ-ede Asia

Abajade ni iṣẹju 15

Wo Ibiti kikun

olora igbeyewo kit

Ohun elo Atunlo + Smart APP Nikan-Lo Ohun elo Idanwo Yiyara (Standalone) Rinfo, kasẹti, agbedemeji ati awọn ọna kika oni-nọmba

Ultra - ifamọra kutukutu (10–20 mIU/ml hCG)

Rinhoho, kasẹti, ati awọn ọna kika aarin

OEM ni kikun/ikọkọ- iṣakojọpọ aami ti o wa

CE ti samisi fun ọja EU OTC

Wo Ibiti kikun

ohun elo idanwo iyara ọkan ọkan

Awọn panẹli imunoassay fluorescence ti o ga fun cTnI, NT-proBNP, D-Dimer, CK-MB, ati Myoglobin. Ti a ṣe apẹrẹ fun aaye-ti-lilo itọju ninu awọn ẹya irora àyà, awọn ẹka pajawiri, ati awọn eto ilera latọna jijin.

Iwọn pipo ≤ 0.1 ng/mL fun ṣiṣe ipinnu pataki

Abajade ni iṣẹju 8-15 lati gbogbo ẹjẹ

Reader-ibaramu fun iroyin pipo

Ifọwọsi ile-iwosan lodi si awọn ọna yàrá aarin

Wo Ibiti kikun

tumo sibomiiran dekun igbeyewo kit

Awọn igbelewọn ibojuwo iyara fun AFP, CEA, PSA, ati awọn ami ami oncology bọtini miiran - muu ni iraye si, ni kutukutu-stratification eewu ipele ni ibojuwo ilera agbegbe ati awọn eto oncology alamọja.

Pipo fluorescence & ologbele-pipo

Iwọn ayẹwo kekere (50-100 µL omi ara / pilasima)

Ṣiṣayẹwo iyara fun awọn eto ilera olugbe

Páńẹ́lì àkópọ̀ àsàmì púpọ̀ wà

Wo Ibiti kikun

iredodo sibomiiran dekun igbeyewo kit

Awọn igbelewọn CRP Rapid, PCT, ati SAA fun iwadii iyatọ iyara ti kokoro-arun dipo awọn akoran ọlọjẹ - pataki fun awọn eto iriju aporo ati ipinya sepsis ni ile-iwosan mejeeji ati awọn eto itọju akọkọ.

CRP + SAA konbo fun ibojuwo akoran okeerẹ

PCT fun sepsis ati ibojuwo ICU

Ika-pa odidi ẹjẹ mu

Awọn abajade laarin awọn iṣẹju 10 ni ẹgbẹ ibusun

Wo Ibiti kikun

ti ogbo dekun igbeyewo irin ise

Awọn eya-awọn idanwo iwadii iyara kan pato fun aja, feline, ati awọn ọlọjẹ ẹran-ọsin. Apẹrẹ fun awọn ile-iwosan ti ogbo, awọn ile-iwosan ẹranko, ati awọn eto iwo-kakiri arun ogbin ti o nilo iyara, awọn abajade aaye igbẹkẹle.

Awọn panẹli elege ati feline (Parvovirus, Distemper, FeLV, FIV)

Ko si tutu-ẹwọn ti a beere lakoko lilo aaye

Aami OEM aṣa fun awọn olupin kaakiri ti ogbo

Wo Ibiti kikun

Didara ni Gbogbo Igbesẹ

GMP-Ifọwọsi 6-Ipele IVD Ilana Ṣiṣelọpọ Apo Idanwo Yara

Gẹgẹbi ile-iṣẹ kan-asiwaju In Vitro Diagnostic (IVD), iṣelọpọ Lateral Flow Assay (LFA) wa tẹle iṣakoso to muna, GMP-itọpa ibamu. Lati agbekalẹ ohun elo aise si idasilẹ ipari ipari, gbogbo ohun elo idanwo ni afọwọsi QA/QC to lagbara lati ṣe iṣeduro ifamọ atupale giga, ipele iwonba-si- iyatọ ipele, ati ibamu ni kikun pẹlu awọn iṣedede ilana agbaye.

01

NC Membrane konge aso

Lilo giga - awọn apinfunni pipe lati bo awọn membran Nitrocellulose ni deede pẹlu awọn antigens/agbogun ara ti a sọ di mimọ, ti n ṣe agbekalẹ awọn laini idanwo ọtọtọ ati igbẹkẹle.

02

Conjugate paadi Igbaradi

Awọn paadi gilaasi saturating pẹlu goolu colloidal iṣapeye tabi awọn asami Fuluorisenti, atẹle nipasẹ afọwọsi iwuwo opiti lile lati ṣe idiwọ awọn idaniloju eke.

03

Ọriniinitutu-Gbigbe ti iṣakoso

Itọju gbogbo awọn ohun elo ti a tọju ni awọn yara gbigbẹ pataki (RH ≤ 20%) lati tiipa ni iṣẹ ṣiṣe ti amuaradagba ati rii daju iduroṣinṣin igba pipẹ.

04

Nto & konge Ige

Pipa awọn paati sori awọn kaadi ifẹhinti alemora ati lilo awọn slitters adaṣe adaṣe lati ge awọn ila si awọn iwọn milimita deede (fun apẹẹrẹ, 3.0mm, 4.0mm).

05

Apo Bankanje akọkọ

Idaduro adaṣe ti awọn ila/kasẹti kọọkan sinu iṣoogun-awọn apo bankanje ipele lẹgbẹẹ giga-awọn ohun elo mimu gbigba lati ṣe iṣeduro igbesi aye selifu 24-oṣu.

06

Ik QC & Tu

Iṣapeye Pupo laileto fun ifamọ atupale ati agbelebu-idanwo ifasẹyin ṣaaju ki o to apoti adaṣe adaṣe ati isamisi fun ibamu si okeere okeere.

Laihe Biotech IVD manufacturing facility

0+ Awọn ọdun IVD
Amoye

Nipa Laiihe Biotech

Olupese POCT Fidimule ni Ifọwọsi Imọ-jinlẹ

Laihe Biotech ti n ṣe awọn ohun elo idanwo iwadii iyara ni Hangzhou lati ọdun 2012. A n ṣakoso pq iṣelọpọ IVD ni kikun ni ile — lati ibojuwo egboogi ati igbaradi conjugate si awọ awọ ara ati QC ikẹhin. Batch wa aṣoju-si-Onísọdipúpọ ìpele ti iyatọ (CV) jẹ ≤ 5%, ti a fọwọsi lodisi GC/MS tabi LC/MS awọn ọna ìmúdájú ti o da lori idanwo naa.

9200㎡ GMP onifioroweoro

EU IVDR Regulatory Support

Kikun ilana Traceability

MOQ lati awọn kọnputa 5,000

Amoye Ifiṣootọ wa

Multidisciplinary IVD Specialists: Engineering Diagnostic konge

A gbagbọ pq ipese to lagbara bẹrẹ pẹlu awọn ọkan ti o wuyi. Ni atilẹyin nipasẹ ẹgbẹ iyasọtọ ti o ju 120 + awọn alamọja, agbara pataki wa ni idari nipasẹ talenti amọja. Awọn onimo ijinlẹ sayensi Oloye wa, Awọn Onimọ-ẹrọ Biomedical, ati Awọn Auditors QA mu ọdun 15+ ti jinlẹ - iriri fidimule ni Lateral Flow Assay (LFA) R&D, agbekalẹ reagent, ati iwọn - iṣelọpọ soke. A kii ṣe awọn ohun elo idanwo nikan; a ẹlẹrọ konge aisan.

9200㎡ GMP onifioroweoro EU IVDR Regulatory Support Kikun ilana Traceability MOQ lati awọn kọnputa 5,000

R&D Egbe

Ni amọja ni fluorescence immunoassay ati awọn iru ẹrọ goolu colloidal, awọn onimo ijinlẹ sayensi wa ṣakoso gbogbo ilana idagbasoke - lati ibojuwo antibody si iwọn iṣelọpọ-oke - aridaju ile-iṣẹ- ifamọ adari, pato, ati aitasera ipele.

Regulatory Affairs Team

Ti o ni oye daradara ni EU IVDR ati awọn ilana ilana agbaye, ẹgbẹ RA wa n pese ọja alamọdaju - atilẹyin iwọle - ṣe iranlọwọ fun awọn ọja rẹ lati tẹ awọn ọja tuntun ni ibamu, daradara, ati laisi awọn idaduro idiyele.

Tita & Awọn ẹgbẹ iwe

Fluent ni awọn ede pupọ, ẹgbẹ tita wa ṣe idaniloju ibaraẹnisọrọ lainidi lati ibeere lati paṣẹ. Awọn alamọja iwe-ipamọ wa mu ifasilẹ kọsitọmu eka fun ifijiṣẹ didan ni gbogbo igba.

Ẹgbẹ Ipese

Ti o da ni iṣupọ IVD ti ogbo ti Hangzhou, awọn alabaṣiṣẹpọ ẹgbẹ pq ipese wa pẹlu awọn ọgọọgọrun ti awọn olupese ti o rii daju ati ṣakoso ni lile ni gbogbo igbewọle - ni ibamu pẹlu awọn iṣedede didara EU, Guusu ila oorun Asia - awọn ibeere iyara, ati idiyele idiyele - awọn ibeere imunadoko, gbogbo rẹ pẹlu awọn akoko idari asọtẹlẹ.

Iwaju Agbaye

Pade wa ni Awọn ifihan IVD International

Gẹgẹbi olupilẹṣẹ IVD kariaye, Laihe Biotech ṣe ifowosowopo pẹlu awọn olupin kaakiri, awọn alabaṣiṣẹpọ OEM, ati awọn ami iyasọtọ ilera ni kariaye - ipade wọn ni ojukoju ni asiwaju iṣoogun ati awọn ifihan iwadii kaakiri awọn orilẹ-ede 80+.

Igbasilẹ orin ti a fihan

Awọn ọran Aṣeyọri olupin

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

Laihe Biotech lati ṣe afihan Idanwo DOA To ti ni ilọsiwaju ati Awọn solusan Idanwo Oogun Irun ni WHX Bangkok & WHX Labs Bangkok 2026

Ọjọ: Oṣu Keje 8-10, 2026 Ipo: Ile-iṣẹ Apejọ Orilẹ-ede Queen Sirikit, Bangkok, ThailandBooth Nọmba:H64 Laihe Biotechis ni inu-didùn lati kede ikopa rẹ ni WHX Bangkok & WHX Labs Bangkok 2026, ọkan ninu awọn ifihan asiwaju Guusu ila oorun Asia fun labolato.

Ka Ẹkọ Ọrọ ➔

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

Laini Biteech lati ṣafihan awọn solusan idanwo iyara ni WHX & WHX Laini (Medlab Asia & Asia Ilera) Malaysia 2025

Ọjọ: 16-18 Keje 2025 Ibi: Malaysia International Trade and Exhibition Centre (MITEC) Nọmba Booth: S25 Laihe Biotech ni inudidun lati kede ikopa ninu WHX Labs Kuala Lumpur 2025, iṣafihan ilera akọkọ ni Malaysia.

Ka Ẹkọ Ọrọ ➔

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

LYHER Gba Ifọwọsi ANVISA fun Apo Idanwo Antigen Dengue NS1 ni Ilu Brazil!

A ti gba ijẹrisi ọja lati ANVISA.

Ka Ẹkọ Ọrọ ➔

Awọn imudojuiwọn Ile-iṣẹ

Titun IVD iroyin

Laihe Biotech lati ṣe afihan Idanwo DOA To ti ni ilọsiwaju ati Awọn solusan Idanwo Oogun Irun ni WHX Bangkok & WHX Labs Bangkok 2026

Ọjọ: Oṣu Keje 8-10, 2026 Ipo: Ile-iṣẹ Apejọ Orilẹ-ede Queen Sirikit, Bangkok, ThailandBooth Nọmba:H64 Laihe Biotechis ni inu-didùn lati kede ikopa rẹ ni WHX Bangkok & WHX Labs Bangkok 2026, ọkan ninu awọn ifihan asiwaju Guusu ila oorun Asia fun labolato.

Wo Awọn alaye ➔

Instant urine drug test cup step by step guide

Ife idanwo oogun ito lẹsẹkẹsẹ ni igbesẹ nipasẹ itọsọna igbese

Kọ ẹkọ Igbesẹ-nipasẹ-Igbese awọn ilana idanwo oogun ito lẹsẹkẹsẹ lati mu ilọsiwaju dara, dinku awọn aṣiṣe, ati atilẹyin awọn idanwo ibi iṣẹ ti o ni ibamu ati iwe.

Wo Awọn alaye ➔

Complete Guide to Covid-19 Antibody Testing for Global Buyers

Itọsọna pipe si Covid - Idanwo Antibody 19 fun Awọn olura Agbaye

Kọ ẹkọ Covid-19 awọn idanwo ajẹsara: awọn oriṣi, deede, awọn iwe-ẹri, ati bii o ṣe le rii daju awọn olupese ti o ni igbẹkẹle nipa lilo awọn atokọ ayẹwo ati WHO-itọnisọna atilẹyin.

Wo Awọn alaye ➔

How Covid 19 Walgreens Testing works from booking to results

Bawo ni Idanwo Covid 19 Walgreens ṣiṣẹ lati fowo si awọn abajade

Igbesẹ-nipasẹ-Itọsọna igbesẹ si idanwo Walgreens Covid: bii o ṣe le ṣe iwe, kini lati mu wa, ati kini lati nireti ni awakọ-nipasẹ, pẹlu CDC ti o han gbangba- alaye atilẹyin.

Wo Awọn alaye ➔

Covid 19 Test Kits Comparative Analysis PCR vs Antigen

Awọn ohun elo Idanwo Covid 19 Comparative Analysis PCR vs Antigen

Ṣe afiwe Covid - 19 PCR vs awọn idanwo antigen, loye deede vs iyara, ki o yan idanwo to tọ fun irin-ajo, iṣẹ, tabi awọn ami aisan nipa lilo WHO-itọnisọna atilẹyin.

Wo Awọn alaye ➔

Covid 19 Test Free market outlook and trends 2026

Idanwo Covid 19 Iwoye ọja ọfẹ ati awọn aṣa 2026

Gba awọn oye ti o han gbangba lori iwoye ọja ọfẹ fun idanwo Covid-19 fun ọdun 2026, pẹlu awọn aṣa eletan, awọn iyipada idiyele, awọn oṣere pataki, ati data ti WHO ṣe atilẹyin.

Wo Awọn alaye ➔