Factory-Direct IVD Rapid Tests

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

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

Why Importers Choose QL Biotek

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

Factory-Direct Supply

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

CE (IVDR) & ISO 13485

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

20+ Years R&D

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

Export-Ready

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

OEM & Private Label

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

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.

MEDICA DüsseldorfMedlab Middle East (Dubai)Hospitalar São PauloMedical Fair Thailand

Ready to Get a Quotation?

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