IVD OEM / ODM Manufacturing
Progene Bio is a vertically integrated IVD manufacturer. We turn your specifications — analyte panel, cut-offs, packaging, branding — into production-ready rapid test SKUs under our GMP and ISO 13485 quality system.
What we can build for you
| Capability | Details |
|---|---|
| Private label | Custom branding, packaging and IFU |
| Custom panels | Drug-of-abuse cups up to 14 analytes; custom cut-offs |
| Formats | Cassette, strip/dipstick, midstream, panel cup, device |
| Documentation | IFU, datasheet, validation, COA, CE files |
| Registration support | Technical files for country registration |
| QC | Lot-level traceability, internal control line, batch validation |
Typical commercial terms
| MOQ | Product-dependent — low MOQ available on specialty assays |
|---|---|
| Sample | Available on request for evaluation |
| Lead time | Confirm on request (formulation + production) |
| Shipping | Global export; documentation per destination |
Exact MOQ, lead time and pricing are confirmed per project — submit an RFQ.
OEM by product line
- Drug-of-abuse (DOA) OEM — custom panels, cut-offs, tamper-evident cups
- Infectious disease OEM — dengue, malaria, HIV, hepatitis, respiratory
- Cardiac & tumor marker OEM
- Women's health OEM
See our manufacturing process →
Last reviewed: 2026-09-12