Alaabta
▼
1. Tijaabada dawooyinka xadgudubka 2. Baaritaanka cudurka neef-mareenka 3. Tijaabada Cudurada Faafa 4. Tijaabada Caafimaadka Haweenka 5. Tijaabada Calaamadaynta Wadnaha 6. Baaritaanka Calaamadaha Burada 7. Tijaabada Calaamadaha caabuqa 8. Imtixaanka caafimaadka xoolaha
Annaga
▼
1. taariikhda shirkadda 2. shahaadooyinka 3. Dalxiis warshadeed
Xalka Adeegyada Wararka Nala Soo Xidhiidh
privacy settings Dejinta qarsoodiga
Maamul Oggolaanshaha Kukiyada
Si loo bixiyo waayo-aragnimada ugu fiican, waxaan isticmaalnaa tignoolajiyada sida cookies si aan u kaydino iyo/ama u galno macluumaadka qalabka. Oggolaanshaha tignoolajiyadan waxay noo ogolaan doontaa inaan ka baaraandegno xogta sida habdhaqanka wax raadinta ama aqoonsiga gaarka ah ee goobtan. Ogolaanshaha la'aanta ama ka noqoshada ogolaanshaha, waxay si xun u saameyn kartaa sifooyinka iyo shaqooyinka qaarkood.
✔ Waa la aqbalay
✔ Aqbal
Diid oo xidh
X
15+
Sannadihii Wax-soo-saarka
40+
Falanqeeyayaasha Dawooyinka ee la ansixiyay
200M+
Imtixaanada la soo saaro sanadkii
60+
Wadamada Dhoofinta
Adeegyadayada Habaynta

Isbeddel Farsamo qoto dheer oo heer kasta ah

Si fudud kuma dhigno summadaada sanduuq - waxaanu bixinaa injineer wax soo saar oo dhab ah anagoo hubinayna in tijaabooyinka daawada OEM ay la kulmaan shuruuc gaar ah oo suuqa ah, heerarka caafimaad, iyo dhamaadka- rajooyinka isticmaale.

Assay Custom & Multi-Panels Dawooyinka

Si sax ah u habayso guddiga suuqaagu u baahan yahay - isku darka falanqaynta kala duwan ee hal qalab, oo lagu jaangooyay isbeddellada xadgudubka gobolka iyo goynta sharciyeynta maxalliga ah.

  • Ilaa 18 cabbir daroogo oo hal qalab ah
  • Heerarka goynta gaarka ah (SAMHSA, EMCDDA, AS/NZS, bespoke)
  • Kaadida, candhuufta (dareeraha afka), iyo timaha timaha
Codso Xigasho →

Qaabka Qalabka & Nakhshad Jireed

Ku kala saar astaantaada qaabab jireed oo gaar ah. Waxaan bixinaa noocyo kala duwan oo guriyo ah waxaanan wax ka beddeli karnaa qodobbada qaabka iyo nidaamka midabka si ay ugu habboonaato doorashadaada suuqa.

  • Strip, Cassette, Dip-Card, ama qaababka Koobka Isku-dhafka ah
  • Midabada guryaha gaarka ah iyo xaradhka summada
  • Tamper-shaabadaha cad iyo sinnaanta-hubi is dhexgalka
Codso Xigasho →

Baakadaha Summada Gaarka ah

Keen khibrad summad leh oo isku xidhan kartoonka dibadda ilaa kiishka tijaabada shaqsiga ah. Kooxdayada nashqadeynta guriga waxay soo saartaa xirfadle, sharciyo-farshaxan waafaqsan oggolaanshahaaga.

  • Caadi ah-nitrojiin daabacan- boorsooyinka birta ah ee daadsan
  • Galiyo luuqado badan IFU (tilmaamaha isticmaalka).
  • Baakado tafaariiq leh oo calaamadeysan iyo cusbitaal badan -sanduuqa sahayda
Codso Xigasho →

Taageerada Diiwaangelinta Sharciyeynta

Ku-socodka xeerarka qalabka caafimaadka waa mid adag. Waxaan bixinaa dukumeenti farsamo oo dhameystiran iyo hagitaan khabiir oo loo baahan yahay si loo diiwaan geliyo badeecadaada IVD ee gaarka ah.

  • Diiwaanada farsamada ee CE IVDR, FDA, TGA, iyo ANVISA
  • Waxqabadka falanqaynta & xogta daraasadda kiliinikada ee faylka
  • Shahaadooyinka Iibka Bilaashka ah (FSC) iyo ISO 13485 scopes baaxadda
Codso Xigasho →
Buugga Alaabta OEM

Faylasha Tijaabada Degdegga ah ee IVD ee dhamaystiran ayaa loo heli karaa OEM

Kala duwanaanshahayaga OEM wuxuu gaarayaa heerka ugu sarreeya - qaybaha baahida ee barta caalamiga ah

Drugs of Abuse — Urine Tests

Daawooyinka Xadgudubka - Baadhitaanka Kaadi

Hal-koox ayaa u kala soocaya 18-koobab isku dhafan oo dawooyin ah oo loogu talagalay goobta shaqada, bukaan-socodka, iyo barnaamijyada baarista dambi-baarista.

THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2
Hadda weydii →
Drugs of Abuse — Oral Fluid

Daawooyinka Xadgudubka - Dheecaan Afka ah

Tijaabooyin dheecaan afka ah oo aan ahayn wadada dhinaceeda iyo goobta shaqada, oo ay ku jiraan DRUID-hababka u hogaansan isticmaalka sharciga.

THCCOCAMP/MAMPOPIMulti-Guddi
Hadda weydii →
Drugs of Abuse — Hair Tests

Daawooyinka Xadgudubka - Timaha Timaha

Xirmooyinka falanqaynta timaha qulqulka dambe oo bixisa 90-daaqad ogaansho oo loogu talagalay sharci, caymis, iyo baadhis shaqo.

90-Taariikhda MaalintaMulti-GuddiGoynta ELISA
Hadda weydii →
Infectious Disease Rapid Tests

Tijaabooyin Degdeg ah oo Cudurada Faafa

CE-astaanta antigen-ka iyo antibody-ka oo si degdeg ah u baadhaysa calaamadaha cudurrada faafa ee halista ah ee goobaha caafimaadka iyo bulshada.

HIV 1/2HBsAgHargabka A/BCOVID-19 AgDuumada
Hadda weydii →
Pregnancy & Fertility Tests

Imtixaanada Uurka & Dhalmada

Dareenka sare

Xarigga hCGHCG cajaladUkxanta LHMenopause FSH
Hadda weydii →
Cardiac & Tumor Markers

Calaamadaha Wadnaha & Burada

Tijaabooyin degdeg ah oo tayo iyo tiro leh oo daryeel ah oo loogu talagalay xaaladaha degdegga ah ee wadnaha ee degdega ah iyo baaritaanka hore ee burooyinka.

Troponin IBNPD-DimerPSAAFP
Hadda weydii →
Sida aan u Shaqeyno

Habka Waxsoosaarka OEM ee Summada Gaarka ah

La safeeyey in ka badan 15 sano si aad alaabtaada uga qaadato fikradda una bilawdo ganacsi si degdeg ah oo ammaan ah intii suurtagal ah.

  1. La-tashigii Hore & Saxeexa NDA

    Waxaan fulinaa NDA wadajir ah ka hor inta aan la wadaagin faahfaahinta lahaanshaha. Kulanka daah-furka habaysan ayaa markaa daboolaya suuqa la beegsanayo, qaybaha daroogada, gooyay- heerarka, qaabka dookhyada, iyo qiyaasta qiyaasta sanadlaha ah.

    ⏱ 1-3 Maalmo Ganacsi

  2. Tusaalaha Tusaalaha & Xaqiijinta Waxqabadka

    Kooxdayada R&D waxay soo diyaariyaan oo ururiyaan muunado prototype shaqaynaya si waafaqsan tilmaamahaaga. Muunado ayaa laguu soo raray gudaha-qiimaynta shaybaadhka guriga, ansaxinta waxqabadka bukaan-socod, iyo qiimayn horudhac ah oo sharciyeed.

    ⏱ 7-21 Maalmo Ganacsi

  3. Dhamaystirka Farshaxanka & Dukumentiyada Nidaaminta

    Marka muunado la oggolaado, kooxdayada naqshadeynta waxay soo gabagabeynayaan dhammaan farshaxanada baakadaha sumadda gaarka ah. Isla mar ahaantaana, kooxdayada arrimaha sharciyaynta waxay ururiyaan dukumeentiga Farsamada ee diiwaangelinta dawladda hoose.

    10-15 Maalmo Ganacsi

  4. Fulinta Qandaraaska OEM & Waxsoosaarka Tirada Badan ee GMP

    Iyada oo la ansixiyay dukumeenti farshaxanimo iyo sharciyeyn, waxaanu saxeexnay heshiiska sahayda OEM. Dalabkaagu waxa uu galaa wax soo saarka gudaha GMP-qolal nadiif ah oo shati leh oo leh khadadka isku xidhka otomaatiga ah ee soo saarista degdega ah.

    ⏱ 30-45 Maalmo Jadwal

  5. Siideynta QC oo Buuxda & Saadka Caalamiga ah

    Wax kasta oo la maro batari QC ah oo dhamaystiran — cross- panels reactivity, dareen/ gaar ah, degenaansho la dedejiyey, muuqaal - ka hor inta aan Shahaadada Falanqaynta la soo saarin. Markaa waxaanu isku dubbaridaynaa xamuulka bakhaarkaada.

    ⏱ 5-7 Maalmood QC + Rarista
Wanaajinta Wax-soo-saarka

GMP-Sare xirmada tijaabada degdega ah ee la shahaadiyey

ISO Class 8 (100,000) GMP Cleanrooms

ISO Class 8 (100,000) Qolalka Nadiifinta ee GMP

Dhammaan xuubka xuubka, diyaarinta suufka isku dhafka ah, iyo isu imaatinka ugu dambeeya waxay ku dhacaan gudaha cadaadis togan, qayb - la kormeeray ISO Class 8 qolal nadiif ah - loogu talagalay in lagu baabi'iyo wasakhda tallaabo kasta.

Qoyaanka adag (RH ≤ 20%) iyo kontaroolada heerkulku waxay dammaanad qaadayaan xasiloonida noolaha ee antibody

ISO 8Fasalka Nadiifinta
RH ≤20%Xakamaynta qoyaanka
24 Mo.Nolosha shelf
High-Volume Automated Production Lines

Sare

CNC-mashiinada wax lagu gooyo ee la kontoroolo, robotic- xarumaha shirarka ee la caawiyay, nitrogen otomaatig ah - boorsada biyaha lagu shubo

Awooddeena wax-soo-saarku waxay dhaaftaa 100,000 imtixaan oo la dhammeeyey maalintii, taas oo u oggolaanaysa OEM waqtiyada hogaanka wax soo saarka ee 30 ilaa 45 maalmood laga bilaabo saxeexa qandaraaska.

100K+Imtixaanada / Maalinta
30-45Wakhtiga Hogaaminta Maalinta
<5% CVJoogteynta badan
Kalsoonida Nidaaminta

Shahaadooyinka Caalamiga ah ee La aqoonsan yahay

Xaruntayada iyo alaabadayadu waxay la kulmaan heerarka ugu adag ee caalamiga ah ee IVD, iyagoo siinaya alaabtaada OEM aasaas caalami ah oo la aqoonsan yahay, oo tayo leh.

#
Daawo Shahaadada
#
Daawo Shahaadada
#
Daawo Shahaadada
#
Daawo Shahaadada
Sheekooyinka Guusha Lamaanaha

Lagu kalsoon yahay IVD Brands ee Lixda Qaaradood

Iskaashiga OEM muddada-dheer ee noocyada daryeelka caafimaadka, qaybiyeyaasha, iyo wakaaladaha wax iibsiga dawladda ee adduunka oo dhan.

Soo-jeedintooda muunadda ayaa ka dhaqso badan soo-saare kasta oo aanu qiimaynay. Caadada 10-koobka kaadida ee aanu wada shaqaynaynay

Their sampling turnaround was faster than any other manufacturer we evaluated. The custom 10-panel urine cup we co-developed is now our top-selling SKU across the European occupational health market.
David L.Agaasimaha Soo iibsiga - Qaybiyaha IVD, Jarmalka 🇩🇪

Waxaan u baahanahay dukumeenti waafaqsan FDA oo dhan ee gaarka ah Kooxdooda sharciyaynta waxay keeneen dossiers dhamaystiran waxayna si buuxda u taageereen nidaamkayaga diiwaangelinta.

We needed FDA-compliant documentation for our entire private-label drug testing line within a tight timeline. Their regulatory team delivered complete dossiers and fully supported our registration process.
Sarah R.VP ee Alaabta - Calaamadda Daryeelka Caafimaadka, USA 🇺🇸

Saddex sano oo shuraako ah ka dib, joogtaynta wax soo saarkooda iyo ka jawaabitaankooda ayaa ah mid ku dayasho mudan. Waxaan maamulnaa in ka badan laba milyan oo unug sannadkii iyada oo loo marayo xaruntooda iyada oo eber aan lahayn wax baxsasho muhiim ah oo diiwaangashan.

After three years of partnership, their production consistency and responsiveness remain exemplary. We run over two million units annually through their facility with zero critical quality escapes on record.
Maxamed K.Maamulaha Guud - Shirkadda Baadhista, UAE 🇦🇪
Su'aalaha Caadiga ah

OEM Partnership FAQs

Wax kasta oo aad u baahan tahay inaad ogaato ka hor intaadan bilaabin mashruucaaga ugu horreeya annaga.

Waa maxay MOQ ee tijaabooyinka daawada OEM?

5,000 pcs/SKU oo loogu talagalay qaababka cajaladaha iyo xariijinta; 2,000 kumbiyuutarada koobabka isku dhafan. Muunadaha qiimaynta (50-200 unug) oo la heli karo ka hor amarada ganacsiga.

Intee in le'eg ayay qaadanaysaa muunad samaynta OEM?

Habaynta caadiga ah:7-10 maalmood oo shaqo. Hababka cusub ee u baahan horumarinta falanqaynta cusub ama goynta caadada ah-Titration off: 3-6 toddobaad.

Ma taageeri kartaa diiwaangelinta badeecada dalkeena?

Haa - Dhameystiran Dukumiintiyada Farsamo ee CE IVDR, FDA, TGA, iyo ANVISA, oo lagu daray ISO 13485 shahaadooyinka, Ku dhawaaqida Ku-habboonaanta, iyo Shahaadooyinka Iibka Bilaashka ah (FSC).

Miyaad saxiixdaa NDA-yada ka hor wadahadallada farsamada?

Dhab ahaantii. Labada dhinac ee NDA waa la fuliyaa ka hor inta aan la is dhaafsanin macluumaadka lahaanshaha. Lagu heli karo Ingiriis, Shiine, Isbaanish, iyo Jarmal.

Waa maxay wakhtiga hogaanka wax soo saarka guud ee caadiga ah?

30-45 maalmood ka dib saxiixa shaqada Ikhtiyaarada degdega ah ee jira - kala hadal wakhtigaaga kooxdayada iibka.

Ma qeexi karaa goynta gaarka ah ee heerarka fiirsashada?

Haa Waxaan u qaabaynaynaa SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, ama macmiil kasta-goyn la qeexay. Dhammaantood waa la ansaxiyay oo liddi ku ah walxaha tixraaca ee shahaadaysan ka hor wax soo saarka.

Ma bixisaa baakad summada gaarka ah oo buuxda?

Haa - calaamadayntaada guriga qalabka, boorsada bireed, kartoonka dibadda, iyo IFU. Ma jiro magac saaraha oo ku yaal alaabtaada. Faylasha farshaxan ee la tafatirin karo ayaa lagu bixiyay dhamaystirka mashruuca.

Maanta Bilow

Bilow Mashruuca OEM/ODM

Kooxdayadu waxay kaga jawaabaan gudaha24 saacadood oo shaqo ahoo leh soo jeedin horudhac ah iyo qiime muujinaya.

×
privacy settings Dejinta qarsoodiga
Maamul Oggolaanshaha Kukiyada
Si loo bixiyo waayo-aragnimada ugu fiican, waxaan isticmaalnaa tignoolajiyada sida cookies si aan u kaydino iyo/ama u galno macluumaadka qalabka. Oggolaanshaha tignoolajiyadan waxay noo ogolaan doontaa inaan ka baaraandegno xogta sida habdhaqanka wax raadinta ama aqoonsiga gaarka ah ee goobtan. Ogolaanshaha la'aanta ama ka noqoshada ogolaanshaha, waxay si xun u saameyn kartaa sifooyinka iyo shaqooyinka qaarkood.
✔ Waa la aqbalay
✔ Aqbal
Diid oo xidh
X