OEM Cov Kev Pab Cuam Ceev - ODM & Private Label Manufacturing

Peb Customization Services

Deep Technical Customization ntawm Txhua Qib

Peb tsis tsuas yog muab koj lub logo rau ntawm lub thawv - peb xa cov khoom lag luam tiag tiag kom ntseeg tau tias koj cov kev sim tshuaj OEM ua tau raws li cov kev cai tshwj xeeb hauv khw, cov qauv kuaj mob, thiab qhov kawg - cov neeg siv kev cia siab.

Custom Assay & Multi-Drug Panels

Txhim kho raws nraim lub vaj huam sib luag uas koj lub lag luam xav tau - sib txuas ntau cov tshuaj ntsuam xyuas hauv ib lub cuab yeej, suav nrog kev tsim txom hauv cheeb tsam thiab kev tswj hwm hauv cheeb tsam txiav - tawm.

Txog li 18 yam tshuaj tsis nyob hauv ib lub cuab yeej
Kev cai txiav - tawm qib (SAMHSA, EMCDDA, AS / NZS, bespoke)
Cov zis, qaub ncaug (qhov ncauj kua), thiab cov plaub hau matrices

Thov ib daim Quote →

Ntaus hom & Lub cev tsim

Sib txawv koj lub hom phiaj nrog cov qauv ntawm lub cev tshwj xeeb. Peb muab ntau lub tsev pwm pwm thiab tuaj yeem hloov kho daim ntawv thiab cov qauv xim kom haum rau koj qhov kev nyiam ua lag luam.

Strip, Cassette, Dip-Card, lossis Integrated Cup hom
Kev cai vaj tse xim thiab daim ntawv lo engravings
Tamper- pov thawj cov ntsaws ruaj ruaj thiab kev deev luag poj luag txiv- tshawb xyuas kev koom ua ke

Thov ib daim Quote →

Private Label Ntim

Xa ib cohesive hom kev paub los ntawm cov thawv sab nrauv mus rau ib tus neeg kuaj lub hnab. Peb pawg neeg tsim khoom hauv tsev tsim cov kws tshaj lij, kev tswj hwm - ua raws li kev kos duab rau koj qhov kev pom zoo.

Kev cai - luam tawm nitrogen - yaug ntawv ci hnab
Multi-hais lus IFU (Cov Lus Qhia rau Kev Siv) inserts
Branded khw muag khoom cartons thiab tsev kho mob tej khoom - thawv khoom

Thov ib daim Quote →

Regulatory File Support Support

Kev tswj xyuas cov cuab yeej siv kho mob yog qhov nyuaj. Peb muab cov ntaub ntawv ua tiav thiab cov kws tshaj lij cov lus qhia uas xav tau los sau npe koj tus kheej - daim ntawv lo IVD khoom thoob ntiaj teb.

Technical dossiers rau CE IVDR, FDA, TGA, thiab ANVISA
Analytical kev ua tau zoo & kev tshawb fawb soj ntsuam cov ntaub ntawv ntawm cov ntaub ntawv
Daim Ntawv Pov Thawj Muag Khoom Dawb (FSC) thiab ISO 13485 cov ntaub ntawv

Thov ib daim Quote →

OEM Khoom Catalog

Comprehensive IVD Rapid Test Portfolio Muaj rau OEM

Peb cov OEM ntau tshaj qhov siab tshaj plaws - xav tau pawg hauv ntiaj teb taw tes - ntawm - saib xyuas kev kuaj mob, txhua tus tsim nyob rau hauv tib GMP - ntawv pov thawj zoo.

Tshuaj Txhaum Cai - Kev kuaj zis

Ib leeg - vaj huam sib luag strips rau 18- tshuaj sib xyaw khob rau chaw ua hauj lwm, chaw kho mob, thiab kev soj ntsuam kev soj ntsuam.

THCCOCAMP/MAMOPI / PABTSO/MDMAFYL/K2

Nug Tam sim no →

Tshuaj Txhaum Cai - Cov kua hauv qhov ncauj

Tsis yog - kev ntxeem tau ntawm txoj kev thiab chaw ua haujlwm qhov ncauj qhov ncauj, suav nrog DRUID - cov cuab yeej ua raws li txoj cai rau kev siv txoj cai.

THCCOCAMP/MAMOPIMulti- Vaj Huam Sib Luag

Nug Tam sim no →

Tshuaj Txhaum Cai - Cov plaub hau kuaj

Lateral flow hair analysis kits muab 90-hnub nrhiav qhov rais rau kev cai lij choj, kev tuav pov hwm, thiab kev soj ntsuam kev ua hauj lwm.

90- Hnub Keeb KwmMulti- Vaj Huam Sib LuagELISA Cutoffs

Nug Tam sim no →

Cov Kab Mob Sib Kis Ceev Ceev

CE - cim cov tshuaj tiv thaiv kab mob thiab tshuaj tiv thaiv kab mob sai rau cov kab mob sib kis tseem ceeb hauv chaw kho mob thiab hauv zej zog.

HIV 1/2HBsAgInfluenza A/BCOVID - 19 AgMalaria

Nug Tam sim no →

Pregnancy & Fertility Tests

Siab - rhiab heev hCG, LH, thiab FSH cov kev ntsuam xyuas rau cov neeg siv khoom thiab chaw kho mob kev lag luam nrog dav ntiag tug - daim ntawv xaiv.

hCG sawbhCG cassetteLH ovulationFSH Menopause

Nug Tam sim no →

Cardiac & Tumor Markers

Point-of-care qualitative and quantitative quick tests for mob plawv mob ceev thiab kuaj qog nqaij hlav ntxov.

Troponin IBNPD - DimerPSAAFP

Nug Tam sim no →

Peb Ua Li Cas

Private Label OEM Manufacturing txheej txheem

Refined tshaj 15 xyoo coj koj cov khoom los ntawm lub tswv yim mus rau kev lag luam tawm sai thiab ruaj ntseg li sai tau.

Initial Consultation & NDA Kos Npe

Peb ua kom muaj kev sib nrig sib NDA ua ntej cov ntsiab lus uas muaj tswv tau muab qhia. Ib qho kev tshawb pom kev sib tham tom qab ntawd suav nrog lub hom phiaj kev lag luam, cov tshuaj siv tshuaj, txiav tawm cov qauv, hom kev nyiam, thiab kwv yees qhov ntim txhua xyoo.
⏱ 1-3 Hnub Ua Lag Luam
Prototype Sampling & Performance validation

Peb pab pawg R & D tsim thiab sib sau ua ke cov qauv qauv ua haujlwm raws li koj qhov tshwj xeeb. Cov qauv raug xa tuaj rau koj rau hauv-kev tshuaj ntsuam xyuas hauv tsev, kuaj xyuas kev ua haujlwm zoo, thiab kev tswj xyuas ua ntej-kev ntsuas.
⏱ 7–21 Hnub Ua Haujlwm
Artwork Finalization & Regulatory Documentation

Thaum kuaj pom zoo, peb pab neeg tsim ua tiav tag nrho cov khoom ntiag tug - daim ntawv lo ntim cov duab kos duab. Nyob rau tib lub sijhawm, peb pab pawg tswj hwm kev tswj hwm suav sau Daim Ntawv Teev Npe rau koj cov cai hauv cheeb tsam sau npe.
⏱ 10-15 Hnub Ua Haujlwm
OEM daim ntawv cog lus ua tiav & GMP pawg ntau lawm

Nrog kev kos duab thiab cov ntaub ntawv tswj kev pom zoo, peb kos npe rau daim ntawv cog lus OEM. Koj qhov kev txiav txim nkag mus rau hauv kev tsim khoom hauv GMP - cov chav huv huv nrog cov kab sib dhos ua ke kom nrawm, sib xws.
⏱ 30–45 Hnub
Tag Nrho QC Tshaj Tawm & Kev Lag Luam Thoob Ntiaj Teb

Txhua qhov ntau dhau los ua tiav QC roj teeb - ntoo khaub lig - reactivity panels, rhiab heev / tshwj xeeb, ceev ruaj khov, zoo li - ua ntej daim ntawv pov thawj ntawm kev soj ntsuam yog muab. Peb mam li sib koom freight rau koj warehouse.
⏱ 5-7 Hnub QC + Shipping

Manufacturing Excellence

GMP - ntawv pov thawj ceev ceev cov khoom siv chaw tsim tshuaj paus

ISO Class 8 (100,000) GMP Cleanrooms

All membrane lamination, conjugate pad preparation, and final strip assembly occur inside positively pressurised, particle-monitored ISO Class 8 cleanrooms — engineered to eliminate contamination at every step.

Cov av muaj zog (RH ≤ 20%) thiab kev tswj qhov kub thiab txias tau lees paub kev ruaj ntseg ntawm cov tshuaj tiv thaiv kab mob - antigen conjugates, kom ntseeg tau tias muaj zog 24- hli txee lub neej nyob thoob plaws tag nrho cov khoom OEM.

ISO 8Chav tsev huv

RH ≤ 20%Humidity Control

24 Moj.Txee lub neej

High-Volume Automated Production Lines

CNC - tswj cov tshuab slitting, neeg hlau - pab sib dhos chaw nres tsheb, thiab automated nitrogen - ntim hnab - sealing kab raws li lub ntiaj teb ntim xav tau thaum txo tib neeg - induced variation - ua tiav tsis tu ncua CV nyob rau hauv tag nrho ntau ntau.

Peb lub peev xwm tsim tau ntau tshaj 100,000 qhov kev xeem tiav ib hnub, ua rau OEM ntau lawm cov sij hawm ntawm 30 mus rau 45 hnub los ntawm daim ntawv cog lus kos npe.

100K +Kev xeem / Hnub

30–45 : kuvHnub Lead Time

<5% CVKev sib txuam ntau

Regulatory Trust

Cov ntawv pov thawj thoob ntiaj teb lees paub

Peb lub chaw thiab cov khoom ua tau raws li cov qauv IVD thoob ntiaj teb nruj tshaj plaws, muab koj cov khoom OEM rau kev lees paub thoob ntiaj teb, tshawb xyuas lub hauv paus zoo.

Saib daim ntawv pov thawj

Partner Success Dab Neeg

Trusted los ntawm IVD Hom Thoob Ntiaj Teb Rau Six

Ntev - Lub sij hawm OEM kev koom tes nrog kev kho mob hom, distributors, thiab tsoom fwv procurement cov koom haum thoob ntiaj teb.

Lawv cov qauv hloov pauv tau nrawm dua li lwm cov chaw tsim khoom uas peb ntsuas. Cov kev cai 10- vaj huam sib luag tso zis khob peb koom tes-tsim yog tam sim no peb sab saum toj - muag SKU thoob plaws European kev ua lag luam kev noj qab haus huv.

David L.Procurement Director — IVD Distributor, Lub teb chaws Yelemees 🇩🇪

Peb xav tau FDA - cov ntaub ntawv ua raws cai rau peb tus kheej tag nrho - daim ntawv lo tshuaj xyuas kab hauv lub sijhawm nruj. Lawv pab pawg tswj hwm tau xa cov ntaub ntawv tiav thiab txhawb nqa peb cov txheej txheem sau npe.

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

Tom qab peb xyoos ntawm kev sib koom tes, lawv qhov kev tsim khoom sib xws thiab kev ua haujlwm tau zoo ua qauv. Peb khiav ntau dua ob lab units ib xyoos ib zaug los ntawm lawv qhov chaw nrog xoom qhov tseem ceeb ntawm kev khiav tawm ntawm cov ntaub ntawv.

Mohammed K.CEO — Diagnostics Company, UAE 🇦🇪

Cov Lus Nug

OEM Partnership FAQs

Txhua yam koj yuav tsum paub ua ntej pib koj thawj qhov project nrog peb.

MOQ rau OEM tshuaj ntsuam xyuas yog dab tsi?

5,000 pcs / SKU rau cov ntawv cassette thiab strip; 2,000 pcs rau kev sib xyaw khob. Cov qauv ntsuas (50-200 units) muaj ua ntej kev txiav txim coj mus muag.

Ntev npaum li cas OEM coj mus kuaj?

Standard configs: 7-10 hnub ua hauj lwm. Novel formulations xav tau tshiab analyte txoj kev loj hlob los yog kev cai txiav - tawm titration: 3-6 lub lis piam.

Koj puas tuaj yeem txhawb cov khoom sau npe hauv peb lub tebchaws?

Yog - Ua kom tiav Cov Ntaub Ntawv Kev Ua Haujlwm rau CE IVDR, FDA, TGA, thiab ANVISA, ntxiv rau ISO 13485 daim ntawv pov thawj, Kev Tshaj Tawm Txog Kev Ua Haujlwm, thiab Daim Ntawv Pov Thawj Muag Dawb (FSC).

Koj puas kos npe rau NDAs ua ntej kev sib tham?

kiag li. Mutual NDA raug tua ua ntej cov ntaub ntawv ntiag tug sib pauv. Muaj lus Askiv, Suav, Mev, thiab German.

Tus txheej txheem ntau lawm ua lub sij hawm yog dab tsi?

30-45 hnub tom qab kos npe kos duab - tawm thiab ua tiav daim ntawv cog lus. Cov kev xaiv nrawm muaj - tham txog koj lub sijhawm nrog peb pab neeg muag khoom.

Kuv puas tuaj yeem hais qhia kev cai txiav - tawm qib siab?

Yog lawm. Peb tsim rau SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, lossis ib tus neeg siv khoom - txhais txiav tawm. Tag nrho cov validated tiv thaiv cov ntaub ntawv pov thawj siv ua ntej ntau lawm.

Koj puas muab tag nrho cov ntawv ntim khoom ntiag tug?

Yog - koj lub npe ntawm cov khoom vaj khoom tsev, cov hnab ntawv, cov thawv sab nrauv, thiab IFU. Tsis muaj npe chaw tsim khoom ntawm koj cov khoom. Editable artwork cov ntaub ntawv muab rau ntawm qhov project tiav.

Pib Hnub no