About Zhejiang QL Biotech Co., Ltd
Professional IVD manufacturer of colloidal-gold rapid diagnostic tests, based in Hangzhou, China. Pure export orientation, serving 40+ markets worldwide.
Zhejiang QL Biotech Co., Ltd (brand: QL Biotek) designs and manufactures lateral-flow rapid diagnostic tests for human and veterinary use. Our core R&D and management team brings more than 20 years of IVD industry experience, and our production base in Lin'an District, Hangzhou covers a 9,000 m² facility with ISO-class cleanrooms and an annual capacity of up to 100 million tests.
Talk to Lisa about your programme
We supply 60+ SKUs across nine product lines: infectious disease, COVID-19/respiratory, fertility, tumor markers, cardiac markers, drugs of abuse, animal health and bulk uncut sheets for IVD manufacturers. Our export team supports distributors and reagent producers across Africa, the Middle East, Southeast Asia and Latin America with OEM and private-label programs, flexible MOQs and multilingual service (EN/ES/PT/FR/AR).
Factory & Capability
9,000 m² Facility
Purpose-built plant at 178# Chuangye Rd, Qingshanhu Sub-district, Lin'an District, Hangzhou, Zhejiang.
~2,000 m² Cleanrooms
ISO-class cleanroom areas for reagent preparation, conjugation and assembly.
100M Tests / Year
Annual capacity of up to 100 million tests, supporting large public-health tenders.
QC Laboratory
In-house quality control covering raw materials, semi-finished and finished goods.
Certificates & Honor
Our products and quality system are certified for international markets:
| Certificate | Scope |
|---|---|
| CE (IVDR) | EU In-Vitro Diagnostic Regulation conformity for rapid test range |
| ISO 13485 | Medical devices quality management system |
| ISO 9001 | General quality management system |
Milestones
- 2020: Founding team establishes the predecessor company; IVD rapid test lines go into production.
- 2021: Zhejiang QL Biotech Co., Ltd registered; QL Biotek brand launched for the export business.
- 2022: Annual sales exceed RMB 86 million; capacity scales to 100M tests/year.
- 2023–2025: Regular exhibitor at MEDICA Düsseldorf, Medlab Middle East, Hospitalar and Medical Fair Thailand; CE (IVDR) transition completed.
- 2026: New launches incl. Chlamydia nucleic-acid kit (LAMP+ICA); uncut-sheet B2B line expands.