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Comprehensive IVD Product

Sakatulani Rapid Test Kits potengera Diagnostic Category

Monga opanga zovomerezeka padziko lonse lapansi, timapanga mayankho a Point-of-Care Testing (POCT) omwe amapereka kulondola kwachipatala-kulondola. Magulu athu ozindikira mwachangu amatsimikizira zambiri-ku-kusinthasintha, ma CV otsika, komanso kutsatira mosamalitsa malamulo apadziko lonse lapansi kwa ogawa padziko lonse lapansi ndi othandizira azaumoyo.

Comprehensive IVD Product Portfolio

Pogwiritsa ntchito mapulaneti athu okhwima agolide a colloidal ndi fluorescence immunoassay, timapereka mayankho ozama - osunthika ogwirizana ndi zovuta zosiyanasiyana zachipatala.

Drugs of Abuse Test Kits
Gawo 01

Mankhwala a Abuse Test Kits

Zida zathu zoyesera za DOA zimawonetsa zinthu zopitilira 40 zosaloledwa, kuphatikiza cocaine, THC, fentanyl, ndi ma cannabinoids opangira. Zogulitsazo zimakhala ndi mitundu yosiyanasiyana-monga single-panel strips, multi-panel cassettes, integrated to collection cups, and dip cards—okonzedwa powunika mikodzo, madzimadzi amkamwa, ndi tsitsi. Zogulitsa zonse zimakhala ndi chizindikiritso cha CE, kutanthauza kutsata kwathunthu zofunikira zoyendetsera IVDR; Minimum Order Quantity (MOQ) pamasinthidwe okhazikika ndi mayunitsi 5,000.

Onani DOA Solutions →
Respiratory Disease Test Kits
Gawo 02

Zida Zoyesera Matenda Opumira

Konzekerani madipatimenti azadzidzidzi ndi zipatala zokhala ndi kuwunika kwakukulu - sensitivity multiplex. Mapanelo athu opumira amasiyanitsa molondola Chimfine A/B, RSV, ndi COVID-19 kuchokera ku zitsanzo za nasopharyngeal kapena swab ya m'mphuno, zomwe zimathandiza kuyeserera mwachangu komanso kuwongolera moyenera antiviral.

Onani Magulu Opumira →
Infectious Disease Test Kits
Gawo 03

Zida Zoyezera Matenda Opatsirana

Zopangidwira magazi athunthu, seramu, ndi madzi a m'magazi, zoyezera zolimbazi zimazindikira magazi-oyambitsa matenda (HIV, HBV, HCV, Syphilis) ndi matenda am'madera otentha (Malungo, Dengue) omwe ali ndi chidziwitso chapadera. Kutentha-kukhazikika kokhazikika kumatsimikizira kugwira ntchito m'malo ovuta kwambiri.

Dziwani Mayeso Opatsirana →
Women's Health Test Kits
Gawo 04

Zida Zoyezera Umoyo Wamayi

Kupereka mphamvu zodziwikiratu (monga 10-20 mIU/mL ya hCG), zida zathu zowunikira mimba ndi LH zimakonzedwa kuti zigwiritsidwe ntchito mwaukatswiri wama gynecological and OTC pharmacy. Zachinsinsi zonse-zopaka zolemba zilipo kwa ogulitsa.

Onani Mitundu Yathanzi Ya Amayi →
Cardiac Marker Test Kits
Gawo 05

Cardiac Marker Test Kits

Kulimbikitsa malo opweteka pachifuwa ndi kuchuluka kwa ma fluorescence immunoassays. Mapulogalamu athu a cTnI, NT-proBNP, CK-MB, ndi D-Dimer amapereka zowerengera zolondola kwambiri mkati mwa mphindi 15, zomwe ndizofunikira kuti acute myocardial infarction (AMI) alowererepo.

Onani Zolemba Zamtima →
Tumor Marker Test Kits
Gawo 06

Mayeso a Tumor Marker Test Kits

Kuthandizira kupezeka koyambirira-kukhazikika pachiwopsezo, zowunikira mwachanguzi zimazindikira zolembera zazikulu za oncology kuphatikiza AFP, CEA, PSA, ndi FOB. Zofunikira zochepa zachitsanzo zimawapangitsa kukhala abwino pamapulogalamu akulu owunika thanzi la anthu.

Onani Zolemba Zotupa →
Inflammatory Marker Test Kits
Gawo 07

Zida Zoyesera Zoyambitsa Zotupa

Zofunikira pakuwongolera ma antibiotic ndi kasamalidwe ka sepsis. Mayesero athu ofulumira a CRP, PCT, ndi SAA amalola madokotala kuti azitha kuzindikira msanga kusiyana pakati pa matenda a bakiteriya ndi mavairasi omwe ali pafupi ndi bedi la wodwalayo.

Dziwani Mayeso Otupa →
Veterinary Test Kits
Gawo 08

Zida Zoyesera Zanyama

Mitundu-mwachindunji, kuzizira-unyolo-njira zowunikira mwachangu za nyama zomwe zikuyenda nawo (agalu / canine Parvovirus, Distemper) ndi kuyang'anira tizilombo toyambitsa matenda. Amapangidwira kudalirika kwakukulu m'malo am'munda ndi m'chipatala.

Onani Zida Zanyama Zanyama →

Standardized GMP Manufacturing Protocol

Ubwino umapangidwa mu sitepe iliyonse. Dziwani momwe kutsatizana kwathu kokhazikika kwa 6-masitepe kumawonetsetsa kuti zida zilizonse zoyeserera mwachangu zimagwira ntchito popanda kunyengerera pazambiri zowunikira komanso kutsimikizika.

01

Kumamatira kwa Membrane

Mwatsatanetsatane kuyanika kwa high-grade nitrocellulose (NC) nembanemba pa zomatira mochirikiza makadi. Njira yodzichitirayi imatsimikizira kuyenderera kwa capillary ndikukhazikitsa mizere yoyeserera yodalirika.

02

Kukonzekera kwa C/T Solution

Kupanga golide woyengedwa kwambiri wa colloidal kapena fulorosenti-ma conjugates olembedwa. Ma antibodies enieni a Control (C) ndi Mayeso (T) mizere amaperekedwa ndendende ndikutsimikiziridwa motsutsana ndi ma benchmarks okhwima a kuwala.

03

Kuyanika & Kuchiritsa

Zigawo zonse zothandizidwa zimachiritsidwa ndi chinyezi chapamwamba-zipinda zowuma zoyendetsedwa bwino (RH ≤ 20%). Izi zimatseka ntchito yachilengedwe ya mapuloteni, ndikutsimikizira moyo wokhazikika wa 24-mwezi.

04

Kusonkhanitsa & Kudula

Kuphatikizika kokhazikika kwa conjugate, zitsanzo, ndi ma absorbent pads. Ma slitters okonzedwa kenako amadula makadi apamwamba omwe adasonkhanitsidwa kukhala mizere yofanana (monga 3.0mm, 4.0mm) mwatsatanetsatane mamilimita.

05

Packaging Yoyamba

Zingwe kapena makaseti amasindikizidwa mwachinsinsi mu matumba azachipatala - matumba a aluminiyamu opangidwa ndi ma robotic, kuphatikiza ma desiccant omwe amayamwa kwambiri kuti ateteze kuwonongeka kulikonse.

06

Kupaka kwachiwiri

Zikwama zomalizidwa zimayesedwa komaliza mwachisawawa kuti ayesedwenso kuti ayesedwenso asanakhale nkhonya, ma batch coding, ndi kulemba zilembo - kuwonetsetsa kuti kutsatiridwa kwathunthu kukugwirizana ndi malangizo a CE IVDR ndi FDA.

Diagnostics Pamakonzedwe Achipatala Onse

Zida zathu zoyeserera mwachangu zimayikidwa m'malo osiyanasiyana azaumoyo - kuchokera kuzipatala zadzidzidzi zakumidzi kupita kuzipatala zakutali.

Toxicology & Workplace
🧪

Toxicology & Malo Ogwira Ntchito

Mapulogalamu a - Ntchito ndi kuwunika mwachisawawa pa malo ogulitsa mafakitale ndi malo owongolera amadalira mapanelo athu a DOA kuti apeze zotsatira zotetezedwa.

Emergency & Urgent Care
🏥

Zadzidzidzi & Chisamaliro Chachangu

Magulu a ED triage amagwiritsa ntchito mapanelo athu opumira kuti asiyanitse Flu A/B ndi COVID-19, ndikupangitsa kuti tizidzipatula mwachangu pakangopita mphindi zochepa.

Global Health Programs
🌍

Global Health Programs

WHO-ma NGO ogwirizana amayika mayeso athu a matenda opatsirana m'malo ochepa-othandizira poyezera HIV, malungo, ndi chindoko popanda kuzizira.

Reproductive Clinics
🔬

Zipatala zoberekera

Machitidwe a OB/GYN ndi ma njira a OTC amapereka mayeso athu azaumoyo a amayi kuti atsimikizire kuti ali ndi pakati, kuneneratu za kutuluka kwa ovulation, komanso kusintha kwanyengo.

Cardiology & Critical Care
❤️

Cardiology & Care Critical Care

Makaseti athu amtima ndi zida zokhazikika pachifuwa-mayunitsi opweteka, pomwe zotsatira zachangu za troponin zimatsogolera moyo-njira zochizira zovuta.

Oncology Screening
🎗

Kuwunika kwa Oncology

Chiwerengero cha anthu-njira zoyezera khansa zimagwiritsa ntchito kuyesa kwathu kwa chotupa mwachangu ngati mtengo-ogwira ntchito poyamba-kupambana zida zozindikiritsa zoopsa.

Antibiotic Stewardship

Utsogoleri wa Antibiotic

Zipatala zimagwiritsa ntchito mayeso athu othamanga a CRP ndi PCT ngati zosankha-zida zothandizira, kuchepetsa kupereka kwa ma empiric antibiotic posiyanitsa mabakiteriya ndi matenda a virus.

Veterinary Management
🐾

Kasamalidwe ka Veterinary

Kuchokera pazanyama zogwirira ntchito limodzi kupita ku mapologalamu achitetezo chaulimi, kuyesa kwathu kwa ziweto kumathandizira kuzindikira msanga pamasamba.

Ziphaso Zodziwika Padziko Lonse

Machitidwe athu oyendetsera bwino amawunikidwa paokha ndikutsimikiziridwa ndi malamulo okhwima kwambiri padziko lonse lapansi.

Chitsimikizo cha ISO 13485

Zida Zachipatala QMS

Chitsimikizo cha ISO 9001

Quality Management

Satifiketi ya MDSAP

Multi- Country Audit

Brazil ANVISA BGMP

Kufikira Msika waku Brazil

Kupanga Mayeso a Mankhwala a OEM & ODM - Opangidwira Msika Wanu

Timapereka mapeto-mpaka-mapetoOEM ndi ODM ntchitokwa ogulitsa, mitundu yazaumoyo, ndi mabungwe ogula zinthu aboma omwe akufuna mayankho oyera-omwe ali ndi zilembo zodziwikiratu motsatira malamulo amderalo.

  • Mwathunthu Configurable Mankhwala PanelSankhani kuchokera ku 40+ ma antibodies ovomerezeka a mankhwala. Sakanizani mitundu yonse ya mkodzo, malovu, kapena tsitsi mu gulu limodzi - kuphatikiza osanthula omwe akubwera ngati fentanyl, buprenorphine, ndi ma cannabinoids opangira.
  • Zolemba Payekha & Kuyika MwamakondaNtchito yathunthu yopangira zojambulajambula, zoyika zambiri - zinenero za IFU, ndi katoni / thumba lachikwama. MOQ kuchokera ku mayunitsi 5,000.
  • Kudula Kosinthika - Kuchotsa Milingo pa PemphoM'madera omwe amafunikira anthu osavomerezeka (monga DOT, DFWP, EMCDDA), titha kusintha ma cut-offs kuti akwaniritse zomwe mukufuna.
  • Regulatory Kusunga ThandizoZolemba zaukadaulo zolembera chizindikiro cha CE, FDA 510(k), TGA, ANVISA, ndi NMPA kulembetsa - kuchepetsa nthawi yanu-ku-msika mpaka miyezi 6.
60+
Maiko Otumizidwa
200M+
Mayeso Opangidwa Pachaka
15+
Zaka mu IVD Manufacturing

Mafunso Ofunsidwa Kawirikawiri

Nthawi zotsogola zokhazikika ndi masiku 15–25 abizinesi pazachuma ndi masiku 30–45 abizinesi amwambo-olembedwa zolembedwa. Timasunga ma buffer stock of high-volume SKUs kuti tikwaniritse zofunikira zaumoyo wa anthu.

Mwamtheradi. Zitsanzo za zida (nthawi zambiri mayunitsi 5-25 pamzere uliwonse wazinthu) zimapezeka kwa ogawa oyenerera komanso oyesa ma labotale. Zitsanzo zimatumizidwa pamtengo ndi zolemba zonse zaukadaulo kuphatikiza IFU ndi mapepala achitetezo.

Zogulitsa zathu zimakhala ndi chizindikiritso cha CE IVD kuti zitheke msika ku Europe, ndipo zimapangidwa pansi pa ISO 13485-QMS yotsimikizika yowunikira kudzera mu pulogalamu ya MDSAP. Zogulitsa zambiri zimanyamulanso kulembetsa ku Brazil ANVISA.

Zambiri mwa zida zathu zoyeserera mwachangu zimapangidwira kuti zisungidwe mozungulira pa 2–30°C (36–86°F) ndi alumali moyo wa miyezi 18–24, kuzipanga kukhala zokwanira-zoyenera kupereka maunyolo ndi misika popanda kuzizira kosalekeza-maunyolo omanga.

Pemphani Mtengo Wogulitsira

Tiuzeni msika womwe mukufuna, magawo oyesera ofunikira, komanso kuchuluka kwapachaka. Gulu lathu logulitsa padziko lonse lapansi lidzayankha mkati mwa maola 24.

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privacy settings Makonda achinsinsi
Sungani chilolezo
Kuti tipeze zokumana nazo zabwino, timagwiritsa ntchito matekinoloje ngati ma cookie kuti tisunge ndi / kapena pezani chidziwitso. Kuvomera matekinolonolonologies kudzatithandizira kukonza deta monga kusakatula kakoka kapena ma ID apadera patsamba lino. Osavomereza kapena kuchotsa chilolezo, zitha kusokoneza mawonekedwe ena ndi ntchito zina.
Ovomerezeka
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