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Onye Mmepụta Ngwa Nnwale Ngwa IVD Ngwa ...
Onye Mmepụta Ngwa Nnwale Ngwa Ngwa E wuru maka Ndị Na-ekesa Ihe Ndị Chọrọ A pụrụ ịchọpụta Nrubeisi
Conlight Medical na-emepụta ma na-emepụta ngwa nyocha ngwa ngwa - site na nyocha ọgwụ na ọrịa na-efe efe ruo na nnwale mmiri, nri na ihe fọdụrụ n'ihe dị arọ - n'ime ụlọ ọrụ GMP kwadoro yana sistemụ mma ISO 13485 & MDSAP (BSI), ikike FDA 510(k) na ngwaahịa 50+ EU CE kwadoro. Ahịrị mmepụta 8, ikike nkeji 15+/afọ, nkwado OEM/ODM zuru oke.
Asambodo ISO 13485 Asambodo MDSAP (BSI) FDA 510(k) ewepụla — K232228 Asambodo CE nke EU karịrị 160
15M+
Ike nrụpụta nkeji / afọ n'ofe ahịrị mmepụta GMP 8
Iri+
Afọ na Mmepụta IVD
300+
Ndị otu otu
8
Usoro Mmepụta GMP
15M+
Ike nkeji / Afọ
50+
Ngwa ndị EU CE kwadoro
100+
Akwụkwọ ikike ikike na ntinye IP
Ngwaahịa na Ngwọta
Mmepụta Ngwa Nnwale Ngwa Ngwa Otu-Kwụsị, site na Ngwa
A na-emepụta ụdị ọ bụla dị n'okpuru n'ime ụlọ ọrụ na ahịrị GMP nke Conlight ma dị maka ịtụ katalọgụ ọkọlọtọ ma ọ bụ mmemme akara OEM/ODM nkeonwe.
Nnwale Ngwa Ngwa Ọgwụ na Ọrịa Na-efe efe
FDA 510(k) wepụtara ngwa nnwale na iko ọgwụ iri na abụọ (K232228), nke a pụrụ ịhazi maka ihe 2-14 na ihe ruru ihe isii na-emebi ihe, tinyere nnwale ngwa ngwa antigen/antibody na-efe efe na mpempe reagent 14-parameter nke nyocha mmamịrị.
Chọpụta ule ọgwụ na ọrịa na-efe efe →
Ngwa Nnwale Metal Dị Arọ
Ngwa nnwale ngwa ngwa nke colloidal-gold maka mmetọ lead, arsenic na mercury na mmiri, ala, agba, ihe egwuregwu ụmụaka, seramiiki na ngwaahịa ndị ahịa - e wuru maka nyocha nnabata na mmemme nchekwa ndị ahịa.
Chọpụta Ngwa Nnwale Metal Dị Arọ →
Ngwa Nnwale Ogo Mmiri
Mmiri ọṅụṅụ, ọdọ mmiri igwu mmiri, spa na akwarium ule na mita na-ekpuchi chlorine, chloramines, nje bacteria (E. coli) na glyphosate residue — tinyere mita TDS dijitalụ 4-n'ime-1, 7-n'ime-1 na 10-n'ime-1.
Chọgharịa Ngwa Nnwale Mmiri →
Ule ihe fọdụrụ n'ihe oriri na ọrụ ugbo
Ngwa nnwale Colloidal gold immunoassay maka ọgwụ ahịhịa na ọgwụ anụmanụ - gụnyere Glyphosate, Melamine, Ractopamine, Salbutamol, Ceftiofur, Tilmicosin, Oxacillin na β-lactamase - maka nyocha nchekwa nri, anụ na mmiri ara ehi.
Chọpụta Ule Nchekwa Nri →
Ngwa nnwale mmiri ara ehi A1/A2 na mmiri ara ehi
Kaadị nnwale colloidal-gold ngwa ngwa maka njirimara A2-β-casein na mmiri ara ehi, na-akwado ndị na-emepụta mmiri ara ehi na mmemme nkwenye akara A2-milk - tinyere allergies anụ ụlọ na panel nnwale ngwa ngwa maka ahụike.
Chọpụta A1/A2 na Nnwale Anụ Ụlọ →
Mmepe OEM/ODM omenala
Weta akara nke gị, nhazi panel ma ọ bụ ihe achọrọ maka iwu ahịa ebumnuche - Ndị otu nyocha na ndebanye aha nke Conlight na-akwado nhazi omenala, nkwakọ ngwaahịa, ntinye na ndebanye aha CE/FDA/mpaghara.
Malite ajụjụ OEM/ODM → Gịnị Mere Ịkụnye Ìhè
Ihe Mere Ndị Na-ekesa Ihe Nile Ji Họrọ Conlight Dị Ka Onye Mmekọ Mmepụta Ha
GMP
Nha Nrụpụta GMP nke Asambodo
Usoro mmepụta IVD asatọ raara onwe ha nye nwere ikike nhazi nke nkeji 15+/afọ, na-akwado ma iwu nnwale na mmemme OEM/ODM ugboro ugboro.
✓
Nrubeisi Iwu A Na-enyocha
ISO 13485 na MDSAP nke BSI kwadoro; FDA 510(k) kwadoro ule ọgwụ nke nwere panel iri na abụọ (K232228); ngwaahịa 160+ nwere asambodo EU CE.
OEM
OEM/ODM zuru oke na akara nkeonwe
Nhazi panel ahaziri ahazi site na nyocha 2-14, nkwakọ ngwaahịa na ntinye akara nkeonwe, yana nkwado ndebanye aha maka ahịa ebumnuche gị.
Nnyocha na D
Nyocha na Nkà na ụzụ nwere ikike ikike n'ime ụlọ
Ihe karịrị ikike ikike 100 na ntinye akwụkwọ IP, gụnyere ikike ikike mba ụwa mbụ nke China maka ngwa nnwale ahụike - na-enye ndị na-ekesa ya ohere ịnweta panel ọhụrụ n'oge.
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Ahụmịhe nkesa zuru ụwa ọnụ
E zigara ma kwado ngwaahịa ndị a n'ofe North America, Europe, Latin America, Africa na Australia, site n'enyemaka nke ndị obodo mgbe ha resịrị ahịa.
300+
Ndị otu 300+, Nzaghachi ngwa ngwa
Otu ndị ọrụ 300 na-enyocha R&D, QC, ihe gbasara iwu na mgbe erechara ahịa, e wuru ya iji mee ngwa ngwa na arịrịọ omenala na ajụjụ teknụzụ.
Asambodo na Nrubeisi
Asambodo na Nrubeisi Iwu
Ngwa nnwale ngwa ngwa dị nso na mkpebi ahụike na nchekwa, yabụ anyị na-eme ka nkwupụta nrubeisi anyị bụrụ nke a kapịrị ọnụ ma dịkwa mfe ịlele kama ịbụ nke nkịtị.
ISO 13485 Usoro njikwa mma mba ụwa nke akọwapụtara maka imewe, mmepụta na ọrụ ngwaọrụ ahụike. Sistemụ mmepụta Conlight nwere asambodo dịka ọkọlọtọ a si dị.
MDSAP (Mmemme Nyocha Ngwaọrụ Ahụike Otu) Otu nyocha iwu, nke a ma ama n'ọtụtụ ahịa (gụnyere US, Canada, Brazil, Japan na Australia), nke British Standards Institution (BSI) nyere Conlight.
Nwepu FDA 510(k) US FDA nchupu na-egosi na ngwaọrụ ahụ bụ nke a na-ere n'ụzọ iwu kwadoro. Ngwa nnwale ọgwụ nke Conlight nwere panel iri na abụọ na iko nnwale ahụ na-ejide nwepu FDA 510(k), nọmba K K232228.
Akara CE Na-akwado na ngwaahịa na-emezu ihe achọrọ maka ahụike, nchekwa na nchekwa gburugburu ebe obibi nke EU. Ruo Disemba 2023, ngwaahịa 160 nke Conlight's IVD nwere asambodo CE nke EU.
Asambodo na akwụkwọ ndebanye aha zuru oke dị na ebe nbudata anyị ma ọ bụ mgbe ị rịọrọ ya - gwa onye na-ere ahịa gị ka o ziga faịlụ PDF dị mkpa maka ahịa ịchọrọ.
Ngwa
Ebe A Na-eji Ngwa Nnwale Ngwa Anyị
Ụlọọgwụ na Ụlọọgwụ
Nnyocha ọrịa na-efe efe na nyocha mmamịrị maka ebe a na-elekọta ndị ọrịa na ụlọ nyocha.
Ahụike Ebe Ọrụ na Ọrụ
Mmemme nyocha ọgwụ tupu ọrụ na nke a na-eme atụmatụ maka ndị were n'ọrụ na ndị na-ahụ maka ahụike ọrụ.
Ọrụ Gburugburu Ebe Obibi na Mmiri
Mmiri ọṅụṅụ, ọdọ mmiri igwu mmiri na spa maka ndị ọrụ obodo na azụmaahịa.
Nri, Ọrụ Ugbo na Ọgwụgwọ anụmanụ
Nnyocha ihe fọdụrụ n'ọgwụ ndị e ji egbu ahịhịa na ọgwụ anụmanụ maka ụlọ ọrụ nri, ugbo, ndị na-emepụta ihe na ụlọ nyocha nchekwa nri.
Ngwaahịa Mmiri ara ehi na ndị ahịa
Nyocha mmiri ara ehi A1/A2 maka ndị na-emepụta mmiri ara ehi, yana nyocha ígwè dị arọ maka ihe egwuregwu ụmụaka, seramiiki na ngwaahịa ndị ahịa.
Mbubata, Mbupụ na Nkesa
Mmemme akara nkeonwe na OEM maka ndị na-ekesa ngwa nnwale ngwa ngwa akwadoro na ahịa mpaghara ọhụrụ.
Otu Anyị Si Arụ Ọrụ
Site na Ajụjụ ruo na Nnyefe — Usoro OEM/ODM anyị
Ajụjụ na Ndụmọdụ Teknụzụ
Kesaa ihe ndị ị chọrọ ime, usoro ihe omume na ahịa ebe ị na-aga; ndị otu anyị na-enyocha ihe ga-ekwe omume na usoro iheomume.
Nhazi na Nlele
R&D na-ahazi panel ahụ (2-14 nyocha) ma na-emepụta ihe atụ maka nkwenye gị.
Nkwado Iwu na Ndebanye Aha
Ntuziaka gbasara CE, FDA na ihe achọrọ maka ndebanye aha mpaghara maka mba ịchọrọ.
Mmepụta GMP Mass
Mmepụta n'ofe ahịrị mmepụta anyị asatọ a kwadoro yana njikwa mma n'ime usoro.
QC na Asambodo Ikpeazụ
Nnwale mwepụta nke otu, akwụkwọ na nkwakọ ngwaahịa asambodo maka ndị kọstọm na ndị na-ekesa ya.
Ngwakọta na Ahịa Mgbe Ahịa Gasịrị
Nhazi mbupu zuru ụwa ọnụ yana nkwado mpaghara mgbe erechara ahịa maka ajụjụ teknụzụ.
Ajụjụ Ndị A Na-ajụkarị
Ajụjụ Ndị A Na-ajụkarị
Kedu ihe bụ ngwa nnwale ngwa ngwa, kedu ka o si arụ ọrụ?
Ngwa nnwale ngwa ngwa bụ ngwaọrụ nchọpụta in-vitro (IVD) nke na-achọpụta ihe kpọmkwem - metabolite ọgwụ, antigen nje, ihe fọdụrụ na ígwè dị arọ ma ọ bụ kemịkalụ - n'ime ihe nlele dịka mmamịrị, ọbara, mmiri ma ọ bụ nri, nke a na-ejikarị teknụzụ colloidal gold immunoassay (lateral flow). Nsonaazụ na-apụta dị ka ahịrị nnwale a na-ahụ anya n'ime nkeji 5-15, na-enweghị ngwa ụlọ nyocha achọrọ.
Conlight ọ bụ onye nrụpụta ngwa nnwale ngwa ngwa nke nwere ikike?
Ee. Conlight na-arụ ọrụ ebe a na-enye asambodo GMP nwere akara mmepụta IVD asatọ, nwere asambodo ISO 13485 na MDSAP site na BSI, yana ngwa nnwale ọgwụ na iko ya nke nwere panel iri na abụọ bụ FDA 510(k) nke e wepụrụ n'okpuru K232228. Ihe karịrị ngwa nnwale iri ise nwere asambodo EU CE.
Ị nwere ike inye ngwa nnwale ngwa ngwa OEM/ODM ma ọ bụ nkeonwe?
Ee. Anyị na-akwado nhazi panel omenala, nkwakọ ngwaahịa na ihe ntinye nkeonwe, yana ntuziaka ndebanye aha maka ahịa ebumnuche gị. Lee usoro OEM/ODM anyị dị n'elu ma ọ bụ kpọtụrụ anyị ka ịmalite mkparịta ụka gbasara nhazi.
Kedụ asambodo Conlight nwere?
Asambodo ISO 13485 na MDSAP sitere na BSI; FDA 510(k) clearance (K232228) maka ngwa nnwale ọgwụ na iko nke nwere panel iri na abụọ; nakwa, dịka ọ dị na Disemba 2023, asambodo EU CE na ngwaahịa IVD 160, yana ngwaahịa iri na abụọ nwere ndebanye aha China NMPA.
Kedu ihe bụ ọnụọgụ opekempe nke iwu (MOQ) maka ngwa ule ngwa ngwa omenala?
MOQ dabere na panel ahụ, usoro nkwakọ ngwaahịa na asambodo achọrọ. Site na nkeji 15+/afọ nke ikike mmepụta jikọtara ọnụ, anyị nwere ike ịnabata ma obere iwu nnwale maka ndị na-ekesa ngwaahịa ọhụrụ na nnukwu mpịakọta OEM/ODM na-emegharị ugboro ugboro - kesaa panel ebumnuche gị na obodo maka ọnụahịa kpọmkwem.
Ogologo oge ole ka ihe nlele na mmepụta oke na-ewe?
Ihe ndị a na-ejikarị katalọgụ eme ihe na-ebuga ihe nlele n'ime ụbọchị ole na ole nke azụmahịa. Usoro OEM/ODM ahaziri ahazi na-eso ndụmọdụ → nhazi/nnwale → nkwado iwu → usoro mmepụta GMP akọwapụtara n'elu; oge ndu kpọmkwem dabere na mgbagwoju anya nke panel na ndebanye aha ahịa ọ bụla achọrọ.
Kpọtụrụ Anyị
Nweta Nkwupụta Ngwa Nnwale Ngwa Ngwa Gị
Gwa anyị ihe ị chọrọ ime, ahịa na olu gị — ndị otu anyị ga-aza n'ime awa iri abụọ na anọ site na ọnụahịa, MOQ na oge ndu.
Gwa Conlight Medical okwu
Maka arịrịọ katalọgụ, nkọwa OEM/ODM ma ọ bụ ajụjụ iwu, kpọtụrụ anyị ozugbo:
Adreesị Ime ụlọ 201, Nanyu XinCun, Zhujing Town, JinShan District, Shanghai, China
Ekwentị +86 183 4314 7735
ozi-e admin@hkconlight.com
WhatsApp +86 181 1631 0929