OEM Rapid Test Services - ODM & Private Label Manufacturing

Yedu Customization Services

Yakadzika Tekinoroji Customization paManhanho ese

Isu hatisi kungoisa logo yako pabhokisi - tinoendesa chaiyo chigadzirwa engineering kuona kuti OEM yako bvunzo dzezvinodhaka inosangana nemirairo yemusika, zviyero zvekiriniki, uye kupera - zvinotarisirwa nemushandisi.

Custom Assay & Multi-Drug Panels

Gadzirisa chaizvo pani inodiwa nemusika wako - kusanganisa akawanda analyte mumudziyo mumwe chete, wakarongedzerwa kumatunhu ekushungurudzwa maitiro uye yemuno mitemo yekucheka -

Anosvika gumi nemasere emishonga parameter mune imwe mudziyo
Tsika yekucheka - kureba mazinga (SAMHSA, EMCDDA, AS/NZS, bespoke)
Weti, mate (oral fluid), uye matrices ebvudzi

Kumbira Koti →

Device Format & Physical Design

Siyanisa mhando yako neakasarudzika mafomati emuviri. Isu tinopa akawanda edzimba mold uye tinokwanisa kugadzirisa mafomu maficha uye ruvara zvirongwa kuti zvienderane nemusika wako.

Strip, Cassette, Dip - Kadhi, kana Integrated Cup mafomati
Mavara edzimba akasarudzika uye mavara ekunyora
Tamper - zvisimbiso zvinoonekwa uye hupombwe - tarisa kubatanidzwa

Kumbira Koti →

Private Label Packaging

Huya yakabatana brand chiitiko kubva kunze bhokisi kune yega test pouch. Yedu yemukati - dhizaini timu inogadzira nyanzvi, mutemo - inoenderana artwork kuti ubvumire iwe.

Tsika-yakadhindwa nitrogen-homwe yefoiri
Multi-mutauro IFU (Mirairo Yekushandisa) inoisa
Makatoni ezvitoro akadhindwa uye zvakawanda zvechipatara-mabhokisi ekupa

Kumbira Koti →

Regulatory Filing Support

Kufambisa mirairo yemidziyo yekurapa kwakaoma. Isu tinopa akazara ehunyanzvi zvinyorwa uye nhungamiro yehunyanzvi inodiwa kunyoresa yako yakavanzika - label IVD chigadzirwa pasi rese.

Tekinoroji dossiers yeEC IVDR, FDA, TGA, uye ANVISA
Analytical performance & clinical study data pafaira
Mahara Kutengesa Zvitupa (FSC) uye ISO 13485 scope docs

Kumbira Koti →

OEM Chigadzirwa Catalog

Yakakwana IVD Rapid Test Portfolio Inowanikwa yeOEM

Yedu OEM renji inotambanudzira yepamusoro-yekudiwa zvikamu munzvimbo yepasirese-ye-kutarisisa diagnostics, ese akagadzirwa pasi peiyo GMP-yakasimbiswa mhando chimiro.

Mishonga Yekushungurudza - Kuongorora Weti

Single-panel strips kusvika 18-drug integrated cups yebasa, kiriniki, uye forensic screening zvirongwa.

THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2

Bvunza Zvino →

Zvinodhaka Zvekushungurudzwa - Oral Fluid

Isiri - inopindira yemugwagwa uye yebasa bvunzo dzemvura yemuromo, kusanganisira DRUID - nzira inoteedzera zvishandiso zvekushandisa mutemo.

THCCOCAMP/MAMPOPIMulti- Panel

Bvunza Zvino →

Mishonga Yekushungurudza - Bvudzi Miedzo

Lateral flow hair analysis kits inopa 90-day yekuona hwindo remutemo, inishuwarenzi, uye yekuongorora basa.

90-Nhoroondo YemazuvaMulti- PanelELISA Cutoffs

Bvunza Zvino →

Infectious Disease Rapid Tests

EC

HIV 1/2HBsAgFuruwenza A/BCOVID-19 AgMalaria

Bvunza Zvino →

Miedzo Yepamuviri & Nembereko

Yakakwirira - senitivity hCG, LH, uye FSH bvunzo dzevatengi uye dzekiriniki misika ine yakafara yakavanzika-mabhii sarudzo.

hCG StriphCG kasetiLH OvulationFSH Menopause

Bvunza Zvino →

Cardiac & Tumor Markers

Point - ye- kutarisirwa kwemhando uye kuwanda nekukurumidza bvunzo dzeacute moyo emergency uye nekutanga tumor screening.

Troponin IBNPD-DimerPSAAFP

Bvunza Zvino →

Mashandiro Atinoita

Yakavanzika Label OEM Manufacturing process

Yakakwenenzverwa pamusoro pemakore gumi nemashanu kutora chigadzirwa chako kubva kupfungwa kuenda kune kushambadzira kwekutengesa nekukurumidza uye zvakachengeteka sezvinobvira.

Yekutanga Consultation & NDA Kusaina

Isu tinoshandisa NDA yakabatana isati yagovaniswa chero ruzivo rwevaridzi. Chikamu chekutsvaga chakarongeka chinobva chavhara musika unotarwa, mapaneru emishonga, kucheka - kuremerwa zviyero, mafomati zvaunofarira, uye inofungidzirwa vhoriyamu yegore.
⏱ 1–3 Bhizinesi Mazuva
Prototype Sampling & Performance Validation

Yedu R&D timu inogadzira uye inounganidza inoshanda prototype samples maererano nezvako zvakatemwa. Samples dzinotumirwa kwauri kuti in-yemba yekuongorora lab, kiriniki mashandiro ekuita, uye yekudzora pre- ongororo.
⏱ 7–21 Business Days
Artwork Finalization & Regulatory Documentation

Kana masampula atenderwa, timu yedu yedhizaini inopedzisa zvese zvakavanzika - label packaging artwork. Panguva imwe chete, timu yedu yezvemitemo inounganidza Technical Dossier yekunyoreswa kwechiremera chenzvimbo yako.
⏱ 10–15 Business Days
OEM Contract Execution & GMP Misa Kugadzirwa

Nemifananidzo uye zvinyorwa zvemitemo zvakabvumidzwa, isu tinosaina chibvumirano chekugovera cheOEM. Yako odha inopinda mukugadzirwa muGMP - dzakasimbiswa dzakachena dzimba dzine otomatiki mitsara yegungano yekukurumidza, inowirirana kubuda.
⏱ 30–45 Karenda Mazuva
Yakazara QC Kuburitswa & International Logistics

Yese mijenya inopinda yakazara QC bhatiri - muchinjiko - reactivity mapaneru, kunzwisiswa/kujeka, kukurumidza kugadzikana, kutaridzika - Chitupa cheOngororo chisati chapihwa. Isu tinobva taronga zvekutakura kuenda kudura rako.
⏱ 5–7 Mazuva QC + Kutumira

Manufacturing Excellence

GMP - yakasimbiswa nekukurumidza bvunzo kit mugadziri

ISO Kirasi 8 (100,000) GMP Dzimba dzekuchenesa

Yese membrane lamination, conjugate pad kugadzirira, uye yekupedzisira strip assembly inoitika mukati yakamanikidzwa zvakanaka, particle- inotariswa ISO Kirasi 8 dzimba dzakachena - dzakagadzirwa kuti dzibvise kusvibiswa padanho rega rega.

Hunyoro hwakasimba (RH ≤ 20%) uye zvidzoreso zvetembiricha zvinovimbisa kugadzikana kwebiological kweantibody-antigen conjugates, kuve nechokwadi chehupenyu hwakasimba hwemakumi maviri nemana - mwedzi wesherufu pamitsara yese yezvigadzirwa zveOEM.

ISO 8Cleanroom Kirasi

RH ≤20%Humidity Control

24 Mo.Sherufu Hupenyu

Yakakwira - Vhoriyamu Automated Production Lines

NC

Kukwanisa kwedu kugadzira kunodarika zviuru zana bvunzo dzakapedzwa pazuva, zvichiita kuti OEM misa yekugadzira inotungamira nguva dzemazuva makumi matatu kusvika makumi mana nemashanu kubva mukusaina kondirakiti.

100K+Miedzo / Zuva

30–45Zuva Rokutungamirira Nguva

<5% CVKusagadzikana Kwakawanda

Regulatory Trust

Zvitupa zvinozivikanwa pasi rose

Nzvimbo yedu uye zvigadzirwa zvinosangana neyakaomesesa yepasi rose IVD zviyero, zvichipa zvigadzirwa zveOEM yako inozivikanwa pasi rose, inoongororwa mhando hwaro.

View Certificate

Shamwari Kubudirira Nyaya

Kuvimbwa neIVD Brands Mhiri Kwemakondinendi matanhatu

Yakareba

Kuchinja kwavo sampling kwakakurumidza kupfuura chero mumwe mugadziri watakaongorora. Tsika gumi

David L.Procurement Director - IVD Distributor, Germany 🇩🇪

Taida FDA-inoenderana zvinyorwa kune yedu yese yakavanzika-label yekuongorora zvinodhaka mutsara mukati menguva yakaoma. Chikwata chavo chekutonga chakaunza dossiers akazara uye yakatsigira zvizere maitiro edu ekunyoresa.

Sarah R.VP yeZvigadzirwa - Healthcare Brand, USA 🇺🇸

Mushure memakore matatu ekubatana, kusimba kwavo kwekugadzira uye kupindura kunoramba kuri kwemuenzaniso. Isu tinomhanyisa anopfuura mamirioni maviri mayunitsi pagore kuburikidza nenzvimbo yavo ine zero yakakosha mhando yekutiza pane rekodhi.

Mohammed K.CEO - Diagnostics Company, UAE 🇦🇪

Mibvunzo Yakajairika

OEM Kudyidzana FAQs

Zvese zvaunoda kuti uzive usati watanga chirongwa chako chekutanga nesu.

Chii chinonzi MOQ yeOEM zvinodhaka bvunzo?

5,000 pcs/SKU yekaseti uye mafomati emitsetse; 2,000 pcs yemakapu akabatanidzwa. Maevaluation samples (50-200 mayunitsi) anowanikwa pamberi pekutengesa maodha.

Kutora nguva yakareba sei OEM sampling?

Standard configs: 7-10 mazuva ebhizinesi. Novel maumbirwo anoda kutsva analyte kuvandudzwa kana tsika kuchekwa - off titration: 3-6 mavhiki.

Unogona here kutsigira kunyoreswa kwechigadzirwa munyika yedu?

Ehe - yakazara Technical Dossiers yeEC IVDR, FDA, TGA, uye ANVISA, pamwe ne ISO 13485 certs, Declaration of Conformity, uye Yemahara Kutengesa Zvitupa (FSC).

Iwe unosaina maNDA pamberi pehurukuro dzehunyanzvi?

Zvamazvirokwazvo. Mutual NDA inoitwa pasati pachinjanwa chero ruzivo rwevaridzi. Inowanikwa muChirungu, Chinese, Spanish, uye German.

Ndeipi yakajairwa kugadzirwa kwehuwandu hwekutungamira nguva?

30-45 mazuva ekarenda mushure mekusainira artwork - off uye chibvumirano chekuuraya. Sarudzo dzekukurumidza dziripo - kurukura nguva yako neboka redu rekutengesa.

Ndinogona here kutsanangura tsika yekucheka-kubvisa mazinga ekugadzirisa?

Hongu. Isu tinogadzira kuSAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, kana chero mutengi-defined cut-off. Zvese zvakasimbiswa zvichipesana neyakasimbiswa referensi zvinhu zvisati zvagadzirwa.

Iwe unopa yakazara yakavanzika label kurongedza?

Hongu - chiratidzo chako paimba yemudziyo, foil pouch, ekunze katoni, uye IFU. Hapana zita remugadziri pane zvigadzirwa zvako. Mafaira emifananidzo anogadzirika anopihwa pakupedzwa kweprojekiti.

Tanga Nhasi