Professional IVD Manufacturer
of Rapid Diagnostic Tests

Zhejiang QL Biotech Co., Ltd — 60+ CE-marked rapid tests across infectious disease, fertility, cardiac markers, DOA and uncut sheets. Factory-direct OEM & private label for distributors and IVD manufacturers worldwide.

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✔ CE (IVDR)✔ ISO 13485✔ ISO 9001 🚢 40+ export markets
9,000m² factory area
100Mtests capacity / year
60+SKUs, 9 product lines
20+years IVD experience

Product Series

Nine complete lines — one-stop POCT supply for importers, distributors and IVD manufacturers.

Why Importers Choose QL Biotek

Everything a distributor needs from a manufacturing partner, built in.

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Factory-Direct Supply

9,000 m² facility with ISO-class cleanrooms, up to 100 million tests per year — no middleman margin.

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CE (IVDR) & ISO 13485

Certified manufacturing under EU IVDR regulation and ISO 13485 quality management.

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20+ Years R&D

Core team with two decades of IVD experience, 60+ SKUs across 9 product lines.

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Export-Ready

Serving Africa, Middle East, Southeast Asia & LATAM. Multilingual support in EN/ES/PT/FR/AR.

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OEM & Private Label

Custom cassette design, packaging and uncut sheet supply for IVD reagent manufacturers.

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Flexible MOQ

Low minimum orders for qualified distributors and generous sample support for validation.

Meet Us at Global Exhibitions

We exhibit every year — book a meeting with Lisa Zhang in advance.

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MEDICA Düsseldorf

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Medlab Middle East (Dubai)

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Hospitalar São Paulo

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Medical Fair Thailand

Ready to Get a Quotation?

Tell Lisa Zhang your products, target market and estimated quantity — official quotation within 24 hours.

💬 WhatsApp +86 153 0654 9980 ✉ Email Enquiry