Otu ngwa ule ngwa ngwa - Chọgharịa oke ngwaahịa IVD anyị zuru oke

Pọtụfoliyo ngwaahịa IVD zuru oke

Na-eji ọla edo colloidal tozuru oke na ikpo okwu immunoassay fluorescence, anyị na-enye azịza nyocha miri emi - kwụ ọtọ ahaziri maka ụdị ụlọ ọgwụ dị iche iche.

Otu 01

Ngwa nyocha ọgwụ ọjọọ eme ihe

Ihuenyo ngwa ule DOA anyị maka ihe karịrị 40 dị iche iche ihe iwu na-akwadoghị, gụnyere cocaine, THC, fentanyl, na sịntetik cannabinoids. Usoro ngwaahịa a gụnyere ụdị dị iche iche-dị ka otu-obere mperi, multi-obere cassettes, iko nchịkọta agbakwunyere, na kaadị dip—haziri maka nyocha nke mmamịrị, mmiri ọnụ, na ihe nlele ntutu. Ngwaahịa niile nwere akara CE, na-egosi nnabata zuru oke na iwu IVDR; Ọnụ ọgụgụ kacha nta (MOQ) maka nhazi ọkọlọtọ bụ nkeji 5,000.

Nyochaa Ngwọta DOA →

Nkeji 02

Ngwa nyocha nke ọrịa iku ume

Kwadebe ngalaba mberede na ụlọọgwụ nwere nyocha multiplex nwere mmetụta dị elu. Akụkụ iku ume anyị na-ekewa nke ọma Influenza A/B, RSV, na COVID-19 site na otu nasopharyngeal ma ọ bụ imi imi, na-enye ohere ngwa ngwa na nchịkwa mgbochi nje.

Lelee akụkụ iku ume →

Nkeji 03

Ngwa nyocha ọrịa na-efe efe

Ezubere maka ọbara zuru oke, serum na plasma, nyocha ndị a siri ike na-achọpụta ọbara - nje ndị na-ebute ọrịa (HIV, HBV, HCV, Syphilis) na ọrịa na-ekpo ọkụ (Ịba, Dengue) nwere ụdị nchọpụta pụrụ iche. Usoro okpomọkụ-usoro kwụsiri ike na-eme ka arụmọrụ dị na ọnọdụ ihu igwe na-achọsi ike.

Chọpụta ule na-efe efe →

Nkeji 04

Ngwa ule ahụike ụmụ nwanyị

Na-ebuga ultra-nhụta mmalite (dịka, 10-20 mIU/mL maka hCG), afọ ime anyị na ngwa nleba anya ovulation LH bụ nke kachasị maka ojiji ọkachamara gynecology na ụlọ ahịa ahịa OTC. Ngwugwu nzuzo zuru oke dị maka ndị nkesa.

Lee Oke ahụike ụmụ nwanyị →

Nkeji 05

Ngwa ihe nrịbama obi

Inye ebe ihe mgbu obi na-enye ike nwere ọnụọgụ fluorescence immunoassays. Anyị cTnI, NT-proBNP, CK-MB, na D-Paịlụ ule Dimer na-enye ngụpụta nleba anya nke ọma n'ime nkeji iri na ise, dị oke mkpa maka nnukwu myocardial infarction (AMI).

Chọgharịa ihe nrịbama obi →

Nkeji 06

Ngwa ihe nrịbama Tumor

N'ịkwado nnweta n'oge - stratification ihe egwu ogbo, nyocha nyocha ngwa ngwa ndị a na-achọpụta akara oncology isi gụnyere AFP, CEA, PSA, na FOB. Ihe achọrọ nlere dị ala na-eme ka ha dị mma maka mmemme nyocha ahụike ọha mmadụ buru ibu.

Lelee ihe nrịbama Tumor →

Nkeji 07

Ngwa ihe nrịbama ọkụ ọkụ

Ọ dị mkpa maka nlekọta sepsis na ọgwụ nje. Nnwale CRP anyị ngwa ngwa, PCT, na SAA na-enye ndị dọkịta ohere ime ngwa ngwa nyocha dị iche n'etiti nje nje na nje virus ozugbo n'akụkụ akwa onye ọrịa.

Chọpụta ule mkparị →

Nkeji 08

Ngwa ule anụmanụ

Ụdị-kpọmkwem, oyi - yinye- ngwọta nchọpụta ngwa ngwa n'efu maka ụmụ anụmanụ ibe (feline/canine Parvovirus, Distemper) na nlekọta anụ ụlọ pathogen. Emepụtara ya maka ntụkwasị obi dị elu na mpaghara mpaghara na ụlọ ọgwụ.

Nyochaa ngwa anụmanụ →

Protocol nrụpụta GMP ahaziri ahazi

A na-ahazi ogo n'ime usoro ọ bụla. Chọpụta ka usoro mmepụta ọkwa 6 siri ike anyị si achọpụta na ngwa ule ọ bụla na-eme ngwa ngwa na enweghị nkwenye na nghọta nyocha na nkọwapụta.

Ịrapagidesi ike nke Membrane

Nkenke lamination nke elu - ọkwa nitrocellulose (NC) membranes na kaadị nkwado nrapado. Usoro a na-akpaghị aka na-eme ka ọ̀tụ̀tụ̀ ịgbasa capillary n'otu ma guzobe ahịrị ule pụrụ iche, nke a pụrụ ịdabere na ya.

Nkwadebe Ngwọta C/T

Nhazi nke ọla edo colloidal ma ọ bụ fluorescent - conjugates akpọnyere aha. A na-ekesara ahịrị mgbochi mgbochi maka njikwa (C) na ule (T) nke ọma ma kwado ya megide akara njupụta ngwa anya siri ike.

ihicha & Ngwọta

A na-agwọta ihe niile a na-emeso ya na iru mmiri dị elu - Ime ụlọ ihicha a na-achịkwa (RH ≤ 20%). Nke a na-egbochi ọrụ ndu nke protein, na-ekwe nkwa ndụ nchekwa ọnwa 24 kwụsiri ike.

Ịgbakọta & Ịcha

Ngwakọta akpaaka nke conjugate, sample, na pads na-amịkọrọ ihe. Ndị slitters a haziri ahazi wee bee kaadị ndị nna ukwu ahụ gbakọtara n'otu ibe ha (dịka, 3.0mm, 4.0mm) na nkenke milimita.

Nkwakọ ngwaahịa mbụ

A na-emechi ibe ma ọ bụ kasetị n'otu n'otu n'ụzọ ọgwụgwọ n'ime ahụike - obere akpa aluminom ọkwa site na ahịrị mgbakọ roboti, gụnyere ihe na-ekpo ọkụ nke ukwuu iji gbochie mmebi mmiri ọ bụla.

Nkwakọ ngwaahịa nke abụọ

Obere akpa emechara na-enweta nlele ikpeazụ random nza maka cross-nnwale mmeghachi omume tupu ịkụ ọkpọ akpaaka, ntinye ogbe, na labeling — na-eme ka nchọta zuru oke dabara na ụkpụrụ CE IVDR na FDA.

Nchọpụta nyocha gafere ntọala ụlọ ọgwụ ọ bụla

A na-ebuga ngwa ule ngwa ngwa anyị n'ofe gburugburu ebe obibi ahụike dị iche iche - site na ngalaba mberede ụlọ ọgwụ obodo ruo na ọdụ ahụike obodo dịpụrụ adịpụ.

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Toxicology & Ebe ọrụ

Mmemme nyocha tupu ọrụ na enweghị usoro na saịtị mmepụta ihe na ụlọ ndozi na-adabere na ogwe DOA anyị maka nsonaazụ enweghị atụ.

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Ihe mberede & Nlekọta ngwa ngwa

Ndị otu ED na-eji akụkụ iku ume anyị mata ọdịiche Flu A/B na COVID-19, na-eme ka ụkpụrụ kewapụrụ ngwa ngwa n'ime nkeji.

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Mmemme ahụike zuru ụwa ọnụ

Ndị otu WHO jikọtara ọnụ na-ebuga ule ọrịa na-efe efe anyị dị ala - ntọala akụrụngwa maka nyocha HIV, ịba na syphilis na-enweghị agbụ oyi.

🔬

Ụlọ ọgwụ ọmụmụ

Omume OB/GYN na ọwa OTC na-enye ule ahụike ụmụ nwanyị anyị maka nkwenye afọ ime, amụma ovulation, na ọkwa nsọ nwanyị.

❤️

Cardiology & Nlekọta Dị Mkpa

Kaseti nrịbama obi anyị bụ akụrụngwa ọkọlọtọ n'ime igbe - nkeji mgbu, ebe nsonaazụ troponin ngwa ngwa na-eduzi ndụ-ụzọ ọgwụgwọ dị egwu.

🎗

Nyocha Oncology

Atumatu nleba anya n'ọkwa nke ọrịa kansa na-eji nyocha ngwa ngwa akara etuto anyị dị ka ọnụ ahịa - nke mbụ dị irè-Nfefe ngwaọrụ maka njirimara ihe egwu n'oge.

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Usoro nlekọta ọgwụ nje

Ụlọ ọgwụ na-eji ule ngwa ngwa CRP na PCT anyị dị ka mkpebi - ngwá ọrụ nkwado, na-ebelata ọgwụ nje na-edepụta site n'ichepụta nje bacteria na nje virus.

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Nlekọta ọgwụgwọ ọrịa anụmanụ

Site na omume anụmanụ ibe ruo na mmemme biosecurity ugbo, ule anụmanụ anyị na-enyere aka ịchọpụta ọrịa nje ngwa ngwa na saịtị.

Ngwọta omenala

Nrụpụta Nnwale Ọgwụ OEM & ODM - Ewuru maka Ahịa gị

Anyị na-enye njedebe-ruo-njedebeOEM na ODM ọrụmaka ndị na-ekesa, ụdị ahụike, na ụlọ ọrụ nzụta gọọmentị na-achọ ncha ọcha zuru oke- ngwọta nyocha ọgwụ akpọrọ dabara na usoro nhazi mpaghara.

Ogwe ọgwụ nwere ike ịhazi ya nke ọmaHọrọ n'ime ọgwụ mgbochi 40+ kwadoro. Gwakọta ngwakọta ọ bụla nke mmamịrị, mmiri, ma ọ bụ ntutu n'ime otu panel - gụnyere nyocha na-apụta dị ka fentanyl, buprenorphine, na cannabinoids sịntetik.
Nkanye aha onwe & Nkwakọ ngwaahịa ahaziri ahaziỌrụ nka nka zuru oke, ihe ntinye ọtụtụ - asụsụ IFU, yana nkọwa katọn/akpa akpa. MOQ sitere na nkeji 5,000.
Mbipu nwere ike imezi-Ọkwa dị n'ArịrịọMaka ikike na-achọghị - oke nleba anya ọkọlọtọ (dịka, DOT, DFWP, EMCDDA), anyị nwere ike megharia mbelata-mwepu iji mezuo ihe achọrọ gị.
Nkwado ntinye akwụkwọ nchịkwaAkwụkwọ nka zuru oke maka akara CE, FDA 510(k), TGA, ANVISA na ndebanye aha NMPA - na-ebelata oge gị - gaa - ahịa ihe ruru ọnwa isii.

60+

Mba Ejere

200M+

A na-arụpụta ule kwa afọ

15+

Afọ na mmepụta IVD

Ajụjụ a na-ajụkarị

Oge ụzọ ngwaahịa ọkọlọtọ bụ ụbọchị azụmaahịa 15–25 maka ngwaahịa ngwaahịa yana ụbọchị azụmaahịa 30–45 maka iwu ahaziri iche. Anyị na-edobe ngwaahịa nchekwa ihe dị elu - oke SKU maka ihe achọrọ ahụike ọha ngwa ngwa.

Kpamkpam. Ngwa nlele (nke na-abụkarị nkeji 5–25 kwa ahịrị ngwaahịa) dị maka ndị nkesa tozuru oke na ndị nyocha ụlọ nyocha. A na-ebufe ihe nlele na ọnụ ahịa ya na akwụkwọ teknụzụ zuru oke gụnyere IFU na mpempe akwụkwọ data nchekwa.

Ngwaahịa anyị na-ebu akara CE IVD maka ịnweta ahịa ahịa Europe, ma arụpụtara ya n'okpuru ISO 13485- QMS enwetara enwetara site na mmemme MDSAP. Ọtụtụ ngwaahịa na-ebukwa ndebanye aha ANVISA Brazil.

Ọtụtụ n'ime ngwa ule anyị ngwa ngwa ka emebere maka nchekwa ambient na 2–30°C (36–86°F) nwere ndụ nchekwa nke ọnwa 18–24, na-eme ka ha dị mma - dabara n'ịweta ụdọ na ahịa na-enweghị oyi na-aga n'ihu - akụrụngwa akụrụngwa.