Litšebeletso tsa Tlhahlobo tse potlakileng tsa OEM - ODM & Private Label Manufacturing

Litšebeletso tsa rona tsa Customization

Tekanyo e tebileng ea Tekheniki maemong ohle

Ha re behe letšoao la hau lebokoseng feela - re fana ka boenjiniere ba 'nete ba sehlahisoa ho netefatsa hore liteko tsa hau tsa lithethefatsi tsa OEM li kopana le melaoana e ikhethileng ea mmaraka, litekanyetso tsa bongaka, le litebello tsa basebelisi.

Custom Assay & Multi- Liphanele tsa Lithethefatsi

Beakanya hantle phanele eo 'maraka oa hau o e hlokang - ho kopanya li-analyte tse ngata sesebelisoa se le seng, tse lokiselitsoeng ho latela mekhoa ea tlhekefetso ea tikoloho le ho fokotsa melao ea lehae.

Ho fihla ho li-parameter tsa lithethefatsi tse 18 sesebelisoa se le seng
Maemo a ikhethileng (SAMHSA, EMCDDA, AS/NZS, bespoke)
Moroto, mathe (oral fluid), le matrices a moriri

Kopa Khopolo →

Sebopeho sa Sesebelisoa & Moralo oa 'Mele

Arola mofuta oa hau ka mefuta e ikhethang ea 'mele. Re fana ka liforomo tse ngata tsa matlo 'me re ka fetola lintlha tsa sebopeho le merero ea mebala ho lumellana le khetho ea hau ea' maraka.

Liforomo tsa Strip, Cassette, Dip-Card, kapa Integrated Cup
Mebala e tloahelehileng ea matlo le litšoantšo tsa li-label
Tamper-litiiso tse hlakileng le bohlola- hlahloba ho kopanngoa

Kopa Khopolo →

Sephutheloana sa Label ea poraefete

Fana ka boiphihlelo bo momahaneng ba mofuta ho tloha mabokoseng a ka ntle ho ea ho mokotla oa motho ka mong oa tlhahlobo. Sehlopha sa rona sa meralo ea ka hare ho ntlo se hlahisa profeshenale, melao-metsoako e tsamaellanang le mesebetsi bakeng sa tumello ea hau.

Tloaelo- naetrojene e hatisitsoeng- mekotlana ea foil
Multi-puo IFU (Litaelo tsa ho Sebelisa).
Mabokose a mabenkele a rekisoang le bongata ba sepetlele-mabokose a thepa

Kopa Khopolo →

Ts'ehetso ea ho Faela ka Molao

Melao ea ho tsamaisa lisebelisoa tsa bongaka e rarahane. Re fana ka litokomane tse felletseng tsa tekheniki le tataiso ea litsebi tse hlokahalang ho ngolisa lekunutu - label IVD sehlahisoa lefatšeng ka bophara.

Litokomane tsa tekheniki tsa CE IVDR, FDA, TGA, le ANVISA
Ts'ebetso ea tlhahlobo le lintlha tsa thuto ea bongaka faeleng
Litokomane tsa Thekiso ea Mahala (FSC) le ISO 13485 scope docs

Kopa Khopolo →

OEM Sehlahisoa Catalog

Comprehensive IVD Rapid Test Portfolio E Fumaneha bakeng sa OEM

Lethathamo la rona la OEM le akaretsa maemo a holimo ka ho fetisisa-a batloang sebakeng sa lefatše

Lithethefatsi tsa Tlhekefetso - Liteko tsa Moroto

Single-panel strips ho 18-likopi tse kopantsoeng tsa lithethefatsi bakeng sa libaka tsa mosebetsi, tsa bongaka, le mananeo a tlhahlobo ea forensic.

THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2

Botsa Joale →

Lithethefatsi tsa Tlhekefetso - Mokelikeli oa Molomo

Liteko tse sa senyeheng tsa tsela le tsa mokelikeli oa molomo sebakeng sa mosebetsi, ho kenyeletsoa DRUID-mekhoa e lumellanang le lisebelisoa tsa ts'ebeliso ea molao.

THCCOCAMP/MAMPOPIMulti-Paneli

Botsa Joale →

Lithethefatsi tsa Tlhekefetso - Liteko tsa Moriri

Lisebelisoa tsa tlhahlobo ea moriri oa morao-rao li fana ka fensetere ea matsatsi a 90 bakeng sa tlhahlobo ea molao, inshorense le mosebetsi.

90- Nalane ea MatsatsiMulti-PaneliELISA Cutoffs

Botsa Joale →

Mafu a tšoaetsanoang ka potlako liteko

CE - liteko tse potlakileng tsa antigen le antibody bakeng sa matšoao a bohlokoa a tšoaetsanoang maemong a bongaka le a sechaba.

HIV 1/2HBsAgInfluenza A/BCOVID-19 AgMalaria

Botsa Joale →

Liteko tsa Boimana le Bokhachane

Liteko tse phahameng - tsa sensitivity hCG, LH, le FSH bakeng sa limmaraka tsa bareki le tsa bongaka tse nang le likhetho tse pharaletseng tsa poraefete-leibole.

Letlapa la hCGKhasete ea hCGLH OvulationFSH ho Menopause

Botsa Joale →

Matšoao a pelo le hlahala

Ntlha

Troponin IBNPD - DimerePSAAFP

Botsa Joale →

Kamoo re Sebetsang Kateng

Private Label OEM Manufacturing Process

E hloekisitsoe ka lilemo tse 15 ho tlosa sehlahisoa sa hau ho tloha mohopolong ho se qala khoebong ka potlako le ka mokhoa o sireletsehileng kamoo ho ka khonehang.

Therisano ea Pele & Ho saena NDA

Re etsa tumellano ea NDA pele lintlha life kapa life tsa botho li arolelanoa. Seboka se hlophisitsoeng sa ho sibolla se akaretsa 'maraka o reriloeng, liphanele tsa lithethefatsi, maemo a khaotsoeng, likhetho tsa sebopeho, le palo e hakanyetsoang ea selemo.
⏱ 1–3 Matsatsi a Khoebo
Mohlala oa mohlala le netefatso ea ts'ebetso

Sehlopha sa rona sa R&D se etsa le ho kopanya lisampole tse sebetsang tsa prototype ho latela litlhaloso tsa hau. Mehlala e romelloa ho uena bakeng sa tlhahlobo ea lab ea ka tlung, netefatso ea ts'ebetso ea bongaka, le tlhahlobo ea pele ho -
⏱ 7–21 Matsatsi a Khoebo
Mosebetsi oa ho Qetela le Litokomane tsa Taolo

Hang ha lisampole li amohetsoe, sehlopha sa rona sa meralo se phethela mesebetsi eohle ea bonono ea lekunutu-leibole ea ho paka. Ka nako e ts'oanang, sehlopha sa rona sa litaba tsa taolo se bokella Dossier ea Tekheniki bakeng sa ngoliso ea bolaoli ba lehae la hau.
⏱ 10–15 Matsatsi a Khoebo
Phethahatso ea Konteraka ea OEM & Tlhahiso ea Boima ba GMP

Ha litokomane tsa bonono le tsa taolo li amohetsoe, re saena tumellano ea phepelo ea OEM. Odara ea hau e kenya tlhahiso ka GMP-liphaposi tse hloekisitsoeng tse netefalitsoeng tse nang le likhoele tsa ho kopanya tse ikemetseng bakeng sa tlhahiso e potlakileng, e tsitsitseng.
⏱ 30–45 Matsatsi a Khalendara
Phatlalatso e Felletseng ea QC & Lisebelisoa tsa Machabeng

Lotho e 'ngoe le e' ngoe e na le betri e felletseng ea QC - sefapano - liphanele tsa ts'ebetso, kutloisiso / ho hlaka, botsitso bo potlakileng, ponahalo - pele Setifikeiti sa Tlhahlobo se fanoa. Ka mor'a moo re hokahanya thepa ho ea polokelong ea hau.
⏱ 5–7 Matsatsi a QC + Ho Romela

Manufacturing Excellence

GMP-moetsi oa lisebelisoa tsa tlhahlobo tse potlakileng tse netefalitsoeng

ISO Class 8 (100,000) GMP Likamore tse Hloekileng

Li-membrane lamination, ho lokisoa ha pad ea conjugate, le kopano ea ho qetela ea strip li etsahala ka har'a likamore tse hloekileng tsa ISO Class 8 - tse etselitsoeng ho felisa tšilafalo mohatong o mong le o mong.

Mongobo o matla (RH ≤ 20%) le taolo ea mocheso e tiisa botsitso ba likokoana-hloko ba li-antibody-antigen conjugates, ho netefatsa bophelo bo matla ba 24-khoeli ho mela eohle ea lihlahisoa tsa OEM.

ISO 8Sehlopha sa Bohloeki

RH ≤20%Taolo ea Mongobo

24 Mong.Shelf Life

Phahameng-Volume Automated Production Lines

CNC-mechini e laoloang, liroboto- liteishene tsa kopano tse thusoang, le naetrojene e itirisang - mokotla oa metsi - lithapo tse koalang li kopana le litlhoko tsa lefats'e ha li ntse li fokotsa phapang e susumetsoang ke batho - ho fumana CV e tlase ka linako tsohle.

Bokhoni ba rona ba tlhahiso bo feta liteko tse feliloeng tse 100,000 ka letsatsi, e leng se nolofalletsang linako tsa tlhahiso ea lihlahisoa tse ngata tsa OEM tsa matsatsi a 30 ho isa ho a 45 ho tloha ho saena konteraka.

100K+Liteko / Letsatsi

30–45Nako ea ho tsamaisa letsatsi

<5% CVHo tsitsana ha Lota

Trust Regulatory

Litifikeiti tse Ananeloang Machabeng

Mehaho le lihlahisoa tsa rona li kopana le litekanyetso tse thata ka ho fetisisa tsa IVD tsa lefats'e, li fa lihlahisoa tsa hau tsa OEM motheo oa boleng bo amohelehang lefatšeng ka bophara.

Sheba Setifikeiti

Lipale Tsa Katleho ea Molekane

E tšeptjoa ke IVD Brands Hohle Lik'honthinenteng Tse Tšeletseng

Likamano tsa nako e telele tsa OEM le mefuta ea tlhokomelo ea bophelo bo botle, barekisi, le mekhatlo ea 'muso ea ho reka thepa lefatšeng ka bophara.

Phetoho ea bona ea lisampole e ne e potlakile ho feta moetsi ofe kapa ofe eo re e hlahlobileng. Tloaelo ea 10-komiki ea moroto eo re e ntlafalitseng e se e le eona e holimo- e rekisoang SKU ho pholletsa le 'maraka oa Europe oa bophelo bo botle ba mesebetsi.

David L.Motsamaisi oa Theko - IVD Distributor, Jeremane 🇩🇪

Re ne re hloka FDA-litokomane tse lumellanang le mohala oa rona oa tlhahlobo ea lithethefatsi tsa lekunutu Sehlopha sa bona sa taolo se ile sa fana ka litokomane tse felletseng mme sa tšehetsa ka botlalo ts'ebetso ea rona ea ho ingolisa.

Sarah R.VP of Products - Healthcare Brand, USA 🇺🇸

Ka mor'a lilemo tse tharo tsa tšebelisano-'moho, tlhahiso ea bona e tsitsitseng le karabelo e lula e le mohlala. Re sebelisa li-unit tse fetang limilione tse peli selemo le selemo ka setsi sa bona se nang le liforomo tsa boleng bo holimo tse tlalehiloeng.

Mohammed K.CEO - Diagnostics Company, UAE 🇦🇪

Lipotso Tse Tloaelehileng

OEM Partnership FAQs

Tsohle tseo o hlokang ho li tseba pele o qala projeke ea hau ea pele le rona.

MOQ ke eng bakeng sa liteko tsa lithethefatsi tsa OEM?

5,000 pcs/SKU bakeng sa li-cassette le lifomate tse hlobolisa; Li-pcs tse 2,000 bakeng sa linoelo tse kopantsoeng. Mehlala ea tlhahlobo (50-200 units) e fumaneha pele ho litaelo tsa khoebo.

Mohlala oa OEM o nka nako e kae?

Litlhophiso tse tloaelehileng: 7-10 matsatsi a khoebo. Litlhahiso tse ncha tse hlokang nts'etsopele ea mohlahlobi e ncha kapa ho khaola ka tloaelo

A na u ka tšehetsa ngoliso ea lihlahisoa naheng ea rona?

Ee - Litokomane tse felletseng tsa Tekheniki bakeng sa CE IVDR, FDA, TGA, le ANVISA, hammoho le litifikeiti tsa ISO 13485, Declaration of Conformity, le Litifikeiti tsa Thekiso ea Mahala (FSC).

Na u saena li-NDA pele ho lipuisano tsa tekheniki?

Ruri. NDA e kopanetsoeng e etsoa pele tlhahisoleseling efe kapa efe ea thepa e fapanyetsanoa. E fumaneha ka Senyesemane, Sechaena, Sepanishe le Sejeremane.

Nako e tloaelehileng ea tlhahiso ea bongata ke efe?

Matsatsi a 30–45 a khalendara ka mor'a ho saena le ho tima konteraka. Likhetho tse potlakileng li fumaneha - buisana le sehlopha sa rona sa barekisi.

A na nka hlakisa maemo a ikhethileng a khaotsoeng?

Ee. Re theha ho SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, kapa moreki ofe kapa ofe-defined cut-off. Tsohle li netefalitsoe khahlano le lisebelisoa tse netefalitsoeng pele ho tlhahiso.

O fana ka sephutheloana sa li-label tsa lekunutu ka botlalo?

Ee - lebitso la hau ntlong ea sesebelisoa, mokotla oa foil, lebokose la kantle, le IFU. Ha ho lebitso la moetsi lihlahisoa tsa hau. Lifaele tsa mosebetsi oa matsoho tse ka fetolehang tse fanoeng ha projeke e phethoa.

Qala Kajeno