About Us
About Nanjing Progene Biotechnology
南京普诺基生物科技有限公司 (Nanjing Progene Biotechnology Co., Ltd) designs and manufactures in-vitro diagnostic (IVD) rapid tests and point-of-care testing (POCT) devices — lateral-flow colloidal-gold tests across infectious disease, drug of abuse, cardiac & tumor markers, and women's health.
Inside the Nanjing Facility
Company Profile
| Legal name (Chinese) | 南京普诺基生物科技有限公司 |
|---|---|
| Legal name (English) | Nanjing Progene Biotechnology Co., Ltd |
| Founded | 2015 |
| Address | No. 26, Hengguang Road, Qixia District, Nanjing, Jiangsu, China |
| Manufacturing license | 苏药监械生产许20240173号 (SYJXSCX20240173) |
| Export certificate | 苏宁药监械出20252501号 (SNYJXC20252501) |
| Facility | GMP manufacturing facility (Nanjing) |
Technology Platforms
Progene Bio operates four integrated technology platforms, per its published company profile:
- Core raw materials — diagnostic antigens, antibodies and reagents developed in-house.
- POCT — rapid tests across inflammation, cardio-cerebrovascular, hormones, tumor markers and chronic disease.
- Chemiluminescence — cardio-cerebrovascular, tumor markers, gastric function, thyroid and autoimmune antibodies.
- Molecular diagnostics — nucleic-acid detection.
Team origins: affiliated with the Nanjing University laboratory ecosystem.
Quality Systems & Certifications
| Certification | Status |
|---|---|
| CE Marking (IVDD 98/79/EC) | Certified lines (self-declaration, Annex III) |
| ISO 13485:2016 (GB/T 42061) | Certified |
| FDA 510(k) | Claimed (no 510(k) number provided) |
| NMPA | Class I filing (第一类医疗器械备案) |
Certification status reflects the company's published claims; certificate numbers and scope are available on request for buyer qualification.
What We Make
600+ SKUs across 12 product series, exported to 80+ markets. See the product catalog.
OEM / ODM
Private label, custom panels, custom packaging and full kit development — from formulation to production-ready SKUs. Learn about manufacturing →
Company profile and technology-platform information verified against third-party IVD industry listings (小桔灯网 iivd.net). Last reviewed: 2026-09-12.