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privacy settings Nā hoʻonohonoho pilikino
Mālama i ka ʻae Kuki
No ka hāʻawi ʻana i nā ʻike maikaʻi loa, hoʻohana mākou i nā ʻenehana e like me nā kuki no ka mālama ʻana a/a i ʻole ke kiʻi ʻana i ka ʻike ʻikepili. ʻO ka ʻae ʻana i kēia mau ʻenehana e ʻae iā mākou e hana i ka ʻikepili e like me ka nānā ʻana a i ʻole nā ​​ID kūʻokoʻa ma kēia pūnaewele. ʻAʻole ʻae a ʻae ʻole i ka ʻae, hiki ke hoʻopilikia i kekahi mau hiʻohiʻona a me nā hana.
✔ Ua ʻae ʻia
✔ E ʻae
Hōʻole a pani
X
15+
Makahiki o ka hana ana
40+
Nā Analytes Laau Hoʻopaʻa ʻia
200M+
Hana ʻia nā hoʻokolohua i kēlā me kēia makahiki
60+
Nā ʻāina hoʻokuʻu aku

Hoʻopilikino ʻenehana hohonu ma kēlā me kēia pae

ʻAʻole mākou e kau wale i kāu hōʻailona ma kahi pahu - hāʻawi mākou i ka ʻenekinia huahana maoli e hōʻoia ana i kāu hoʻāʻo lāʻau OEM e hoʻokō i nā lula mākeke kikoʻī, nā kūlana lapaʻau, a me nā manaʻolana hope-mea hoʻohana.

ʻO ka hoʻāʻo maʻamau a me ka lehulehu-Panela lāʻau

E hoʻonohonoho pono i ka panel e pono ai kāu mākeke - ka hui pū ʻana i nā analytes he nui i ka mea hoʻokahi, calibrated i nā ʻano hana hoʻomāinoino kūloko a me nā ʻoki hoʻoponopono kūloko.

  • A hiki i 18 mau palena lāʻau i loko o ka mea hoʻokahi
  • Nā pae oki-off maʻamau (SAMHSA, EMCDDA, AS/NZS, bespoke)
  • ʻO ka mimi, kohu (wai waha), a me nā matrices lauoho
Noi i kahi ʻōlelo →

ʻAno Mea Hana & Hoʻolālā Kino

E hoʻokaʻawale i kāu hōʻailona me nā ʻano kino kūikawā. Hāʻawi mākou i nā ʻāpana hale he nui a hiki ke hoʻololi i nā kumu kumu a me nā kala kala e kūpono i kāu makemake mākeke.

  • Strip, Cassette, Dip-Card, a i ʻole nā ʻano kīʻaha i hoʻohui ʻia
  • Nā kala hale maʻamau a me nā kaha kaha
  • Hoʻopili-hōʻike sila a me ka moekolohe-e nānā i ka hoʻohui
Noi i kahi ʻōlelo →

Hoʻopili Lepili pilikino

Hāʻawi i kahi ʻike hōʻailona cohesive mai ka pahu pahu waho i ka ʻeke hoʻāʻo pākahi. Hoʻokumu kā mākou hui hoʻolālā hale i ka ʻoihana ʻoihana, hoʻoponopono-kūpono hana no kou ʻae ʻana.

  • Kūlike-paʻi ʻia ʻo nitrogen-flush foil pou
  • Hoʻokomo ʻia ka ʻōlelo IFU (Instructions for Use).
  • Nā pahu kūʻai kūʻai branded a me nā pahu hoʻolako nui o ka haukapila
Noi i kahi ʻōlelo →

Kākoʻo Waihona Hoʻoponopono

He paʻakikī ka hoʻokele ʻana i nā hoʻoponopono lāʻau lapaʻau. Hāʻawi mākou i nā palapala ʻenehana piha a me nā alakaʻi loea e pono ai e hoʻopaʻa inoa i kāu huahana pilikino-label IVD ma ka honua holoʻokoʻa.

  • Nā palapala ʻenehana no CE IVDR, FDA, TGA, a me ANVISA
  • Hana analytical a me ka ʻikepili noiʻi ma ka waihona
  • Nā Palapala Kūʻai manuahi (FSC) a me nā palapala kikoo ISO 13485
Noi i kahi ʻōlelo →

Loaʻa ʻia ka Portfolio Comprehensive IVD Rapid Test no OEM

ʻO kā mākou hui OEM e pili ana i nā ʻāpana koi kiʻekiʻe loa i ka pae honua-o-nā diagnostics mālama, hana ʻia a pau ma lalo o ka GMP-paʻa maikaʻi i hōʻoia ʻia.

Drugs of Abuse — Urine Tests

ʻO nā lāʻau hoʻomāinoino - nā hōʻike mimi

Hoʻokahi-panel strips i 18-lāʻau i hoʻohui ʻia i nā kīʻaha no nā wahi hana, ke kauka, a me nā papahana nānā forensic.

THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2
E nīnau i kēia manawa →
Drugs of Abuse — Oral Fluid

Laau Laau Hoino — Waiwai waha

ʻAʻole-invasive alanui a me ka wahi hana ho'āʻo wai waha, me DRUID-ʻano hana kūpono no ka hoʻohana kānāwai.

THCCOCAMP/MAMPOPINui-Panel
E nīnau i kēia manawa →
Drugs of Abuse — Hair Tests

ʻO nā lāʻau hoʻomāinoino — Hoʻokolo lauoho

Hāʻawi ʻia nā pahu loiloi lauoho holo hope i kahi puka aniani ʻike 90-lā no ke kānāwai, ʻinikua, a me ka nānā ʻana i ka hana.

90-La MooleloNui-PanelELISA Okioki
E nīnau i kēia manawa →
Infectious Disease Rapid Tests

Nā ho'āʻo wikiwiki o ka maʻi lele

CE-marked antigen and antibody rapid tests for critical infectious disease markers in clinical and community settings.

HIV 1/2HBsAgInfluenza A/BCOVID-19 AgMalaria
E nīnau i kēia manawa →
Pregnancy & Fertility Tests

Nā ho'āʻo hāpai a me ka hānau keiki

Nā ho'āʻo hCG, LH, a me FSH kiʻekiʻe no nā mea kūʻai a me nā mākeke lapaʻau me nā koho kikoʻī ākea ākea.

hCG StripʻO ka pahu hCGLH OvulationFSH Menopause
E nīnau i kēia manawa →
Cardiac & Tumor Markers

Nā Hōʻailona Puʻuwai & Tumor

Point-of-care qualitative and quantitative rapid tests for acute cardiac mergencies and early tumor screening.

ʻO Troponin IBNPD-DimerPSAAFP
E nīnau i kēia manawa →

Kaʻina Hana Hana OEM Label Private

Hoʻomaʻemaʻe ʻia ma mua o 15 mau makahiki e lawe i kāu huahana mai ka manaʻo a hiki i ka hoʻomaka ʻana i ka ʻoihana me ka wikiwiki a me ka palekana.

  1. Kūkākūkā Hoʻomaka & Kaulima NDA

    Hana mākou i kahi NDA ma mua o ka hāʻawi ʻia ʻana o nā kikoʻī waiwai. A laila uhi ʻia kahi hālāwai ʻike i kūkulu ʻia i ka mākeke makaʻāina, nā panela lāʻau, ʻoki-off maʻamau, nā makemake format, a me ka nui o ka makahiki.

    ⏱ 1–3 mau lā ʻoihana
  2. Ka Laʻana Laʻana a me ka hōʻoia hana

    Hoʻokumu a hōʻuluʻulu kā mākou hui R&D i nā laʻana prototype hana i kāu mau kikoʻī. Hoʻouna ʻia nā laʻana iā ʻoe no ka loiloi ʻana i loko o ka hale, ka hōʻoia ʻana i ka hana lapaʻau, a me ka loiloi mua.

    ⏱ 7–21 mau lā ʻoihana
  3. Hoʻopau ʻana i nā hana noʻeau a me nā palapala hoʻoponopono

    Ke ʻae ʻia nā laʻana, hoʻopau kā mākou hui hoʻolālā i nā hana kiʻi paʻi paʻi inoa pilikino. I ka manawa like, hoʻohui kā mākou hui hoʻoponopono i ka Technical Dossier no ka hoʻopaʻa inoa ʻana i kāu mana kūloko.

    ⏱ 10–15 mau lā ʻoihana
  4. Hoʻokō 'aelike OEM & GMP Mass Production

    Me ka hana noʻeau a me nā palapala hoʻoponopono i ʻāpono ʻia, kau inoa mākou i ka ʻaelike hoʻolako OEM. Hoʻokomo kāu kauoha i ka hana ʻana ma GMP-nā lumi hoʻomaʻemaʻe i hōʻoia ʻia me nā laina hui ʻakomi no ka hoʻopuka wikiwiki ʻana.

    ⏱ 30–45 mau lā Kalena
  5. Hoʻokuʻu piha QC & Logistics International

    Loaʻa nā ʻāpana āpau i kahi pākaukau QC piha - cross-reactivity panels, sensitivity/specificity, accelerated stability, hiʻona - ma mua o ka hoʻopuka ʻia ʻana o kahi palapala hōʻoia. A laila hoʻonohonoho mākou i ka ukana i kāu hale kūʻai.

    ⏱ 5-7 mau lā QC + Hoʻouna

GMP-mea hana pahu ho'āʻo wikiwiki i hōʻoia ʻia

ISO Class 8 (100,000) GMP Cleanrooms

ʻO ka papa ISO 8 (100,000) nā lumi hoʻomaʻemaʻe GMP

ʻO ka lamination membrane a pau, ka hoʻomākaukau ʻana i ka pad conjugate, a me ka hui hope ʻana i loko o nā lumi hoʻomaʻemaʻe maikaʻi, particle-monitored ISO Class 8 — hoʻomaʻemaʻe ʻia e hoʻopau i ka haumia i kēlā me kēia pae.

ʻO ka haʻahaʻa haʻahaʻa (RH ≤ 20%) a me nā mana wela e hōʻoiaʻiʻo i ka paʻa olaola o nā antibody-antigen conjugates, e hōʻoia ana i kahi ola paʻa 24-mahina ma waena o nā laina huahana OEM.

ISO 8Papa Maemae
RH ≤20%Hoʻomalu Humidity
24 Mo.Ola Pahu
High-Volume Automated Production Lines

Kiekie-Volume Automated Production Lines

ʻO CNC-nā mīkini ʻokiʻoki i hoʻopaʻa ʻia, robotic-nā kahua hui kōkua, a me ka nitrogen automated-flush pouch-sealing lines e hoʻokō i nā koi nui o ka honua me ka hoʻohaʻahaʻa ʻana i ke ʻano o ke kanaka-induced - e loaʻa mau ana ka CV haʻahaʻa ma nā wahi āpau.

ʻOi aku ka nui o kā mākou hana hana ma mua o 100,000 mau hoʻokolohua i hoʻopau ʻia i kēlā me kēia lā, e ʻae ana i nā manawa alakaʻi hana nui OEM o 30 a 45 mau lā mai ka pūlima ʻaelike.

100K+Nā ho'āʻo / lā
30–45Lā Manawa
<5% CVLot Consistent

Nā palapala hōʻoia i ʻike ʻia ma ka honua

Hoʻokō kā mākou hale hana a me nā huahana i nā kūlana koʻikoʻi o ka honua IVD, e hāʻawi ana i kāu huahana OEM i ʻike ʻia ma ke ao holoʻokoʻa.

Ua hilinaʻi ʻia e IVD Brands ma nā ʻāina ʻeono

ʻO nā hui OEM lōʻihi me nā hōʻailona mālama ola, nā mea hoʻolaha, a me nā keʻena kūʻai aupuni a puni ka honua.

ʻOi aku ka wikiwiki o kā lākou huli ʻana ma mua o nā mea hana ʻē aʻe a mākou i loiloi ai. ʻO ke kīʻaha mimi 10-panel a mākou i hoʻomohala ai i kēia manawa ko mākou kiʻekiʻe-kūʻai SKU ma waena o ka mākeke olakino ʻoihana ʻEulopa.

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.
ʻO David L.Luna Hoʻokele - IVD Distributor, Kelemānia 🇩🇪

Pono mākou i ka FDA-palapala hoʻokō pono no kā mākou laina hoʻāʻo lāʻau pilikino holoʻokoʻa i loko o kahi manawa paʻa. Hāʻawi kā lākou hui hoʻoponopono i nā dosiers piha a kākoʻo piha i kā mākou kaʻina hoʻopaʻa inoa.

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.
ʻO Sarah R.VP o nā huahana — Healthcare Brand, USA 🇺🇸

Ma hope o ʻekolu mau makahiki o ka launa pū ʻana, hoʻohālike ʻia kā lākou hana ʻana a me ka pane ʻana. Holo mākou ma luna o ʻelua miliona mau ʻāpana i kēlā me kēia makahiki ma o kā lākou hale me ka ʻole o ka maikaʻi koʻikoʻi e pakele ma ka moʻolelo.

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.
ʻO Mohammed K.Luna Nui - Hui Diagnostics, UAE 🇦🇪

Nā nīnau nīnau no ka hui ʻana o OEM

ʻO nā mea āpau e pono ai ʻoe e ʻike ma mua o ka hoʻomaka ʻana i kāu papahana mua me mākou.

He aha ka MOQ no nā hoʻokolohua lāʻau OEM?

5,000 pcs/SKU no nā ʻano cassette a me nā ʻili; 2,000 pcs no nā kīʻaha i hoʻohui ʻia. Loaʻa nā laʻana loiloi (50–200 mau ʻāpana) ma mua o nā kauoha kālepa.

Pehea ka lōʻihi o ka lawe ʻana o OEM sampling?

Nā hoʻonohonoho maʻamau: 7-10 mau lā ʻoihana. ʻO nā ʻano hana hou e koi ana i ka hoʻomohala ʻana i ka analyte hou a i ʻole ka hoʻokaʻawale ʻana maʻamau: 3-6 pule.

Hiki iā ʻoe ke kākoʻo i ka hoʻopaʻa inoa huahana ma ko mākou ʻāina?

ʻAe — nā palapala ʻenehana piha no CE IVDR, FDA, TGA, a me ANVISA, me nā palapala hōʻoia ISO 13485, Hōʻike Kūʻai, a me nā Palapala Kūʻai Kūʻai manuahi (FSC).

Ke kau inoa nei ʻoe i nā NDA ma mua o nā kūkākūkā ʻenehana?

ʻOiaʻiʻo. Hoʻokō ʻia ka Mutual NDA ma mua o ka hoʻololi ʻia ʻana o kekahi ʻike ponoʻī. Loaʻa ma ka ʻōlelo Pelekania, Kina, Paniolo, a me Kelemānia.

He aha ka manawa alakaʻi hana nui maʻamau?

30–45 mau lā alemanaka ma hope o ka hōʻailona hana a me ka hoʻokō ʻana i ka ʻaelike. Loaʻa nā koho wikiwiki - e kūkākūkā i kāu kaʻina manawa me kā mākou hui kūʻai.

Hiki iaʻu ke kuhikuhi i nā pae koʻikoʻi maʻamau?

ʻAe. Hoʻokumu mākou i SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, a i ʻole kekahi mea kūʻai-ʻoki ʻia-off. Hoʻopaʻa ʻia nā mea a pau e pili ana i nā mea kuhikuhi i hōʻoia ʻia ma mua o ka hana ʻana.

Hāʻawi ʻoe i ka hōʻailona hōʻailona pilikino piha?

ʻAe — kou hōʻailona ʻana ma ka hale o ka mea hana, ʻeke pepa, pahu pahu waho, a me IFU. ʻAʻohe inoa mea hana ma kāu huahana. Hāʻawi ʻia nā faila hana kiʻi hiki ke hoʻoponopono ʻia i ka pau ʻana o ka papahana.

E hoʻomaka i kāu papahana OEM / ODM

Pane kā mākou hui i loko24 hola ʻoihaname ka manaʻo mua a me ke kumu kūʻai hōʻike.

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privacy settings Nā hoʻonohonoho pilikino
Mālama i ka ʻae Kuki
No ka hāʻawi ʻana i nā ʻike maikaʻi loa, hoʻohana mākou i nā ʻenehana e like me nā kuki no ka mālama ʻana a/a i ʻole ke kiʻi ʻana i ka ʻike ʻikepili. ʻO ka ʻae ʻana i kēia mau ʻenehana e ʻae iā mākou e hana i ka ʻikepili e like me ka nānā ʻana a i ʻole nā ​​ID kūʻokoʻa ma kēia pūnaewele. ʻAʻole ʻae a ʻae ʻole i ka ʻae, hiki ke hoʻopilikia i kekahi mau hiʻohiʻona a me nā hana.
✔ Ua ʻae ʻia
✔ E ʻae
Hōʻole a pani
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