Migibio

OEM/ODM & Manufacturing

Migibio is a POCT veterinary diagnostics manufacturer offering OEM, ODM, and private-label services across the diagnostic workflow — from reagent research and development to analyzer production and quality control. This page describes the capabilities documented in the company’s archived product and corporate pages; it is a capability overview, not a list of performance claims or customer references.

Manufacturing capabilities

The following capabilities are supported by Migibio’s published product attributes and corporate pages:

  • Quantitative fluorescence POCT platform (FICT) — the FIA680 single-channel analyzer, the FIA880 six-channel analyzer, and a canine/feline reagent panel covering infectious disease antigens and antibodies, hormones, inflammatory markers, and organ-function biomarkers.
  • Research and development — biomarker selection, antibody/antigen development, standard-curve design, and cloud-chip updates for downloadable standard curves and software.
  • Production — a standardized 2,000 m² R&D and production workshop operated under ISO 13485 and ISO 9001-certified quality management and GMP principles, with full lot traceability.
  • Quality control — manufacturer-reported platform precision of CV% <10%, pg/ml-level limit of detection, lot-release testing, and assay-specific validation documented in each reagent’s Instructions for Use (IFU).

Independent third-party validation studies are not yet published. Platform-level specifications are manufacturer-reported internal validation data; prospective partners should request the full validation report for the specific assay or analyzer being evaluated.

Certifications & qualifications

Based on the archived company pages currently published on this site, Migibio confirms the following:

  • High-tech biotechnology enterprise, headquartered in Guangzhou Science City
  • ISO 13485-certified quality management system (medical devices and IVDs)
  • ISO 9001-certified quality management system
  • GMP-certified manufacturing processes
  • Guangdong Province “Zhuan Jing Te Xin” (Specialized and Innovative) SME
  • Veterinary Drug Production License
  • 2018 Innovation and Entrepreneurship Competition award
  • 30 core patents
  • Standardized 2,000 m² R&D and production workshop

This page intentionally does not list customer names, order volumes, export figures, or qualifications that are not present in the archived source pages. For certificate scope and current documentation, contact the sales team.

OEM / ODM / private label

Migibio supports three related partnership models:

  • Private label — custom packaging, labeling, and formulation for distributors and brands, as described in the contact FAQ.
  • ODM — rebranding an existing analyzer and reagent line under a partner’s brand, including packaging, manuals, IFU language, and software interface localization.
  • OEM — building to a partner’s specification, such as a custom reagent menu or analyzer modification, with validation and regulatory requirements scoped per project.

Analyzer customization is supported by the published FIA680/FIA880 attributes: language options include Chinese, English, Russian, and Italian, and cloud-chip technology enables custom standard curves, custom reference ranges, online software updates, and recovery of lost ID chips over Wi-Fi. Specific timelines, minimum order quantities, and regulatory responsibilities depend on the customization scope and target market; contact Migibio to scope the project.

Why partner

  • Quantitative differentiation — FICT produces an objective, instrument-read concentration rather than a subjective visual line, unlike conventional qualitative colloidal-gold rapid tests.
  • Cloud-connected standard curves — cloud-chip technology supports downloadable standard curves, custom reference ranges, and online software updates.
  • Integrated system — analyzers and canine/feline reagents are designed as one system, simplifying menu selection and supply planning.
  • Documented quality foundation — ISO 13485, ISO 9001 and GMP-certified manufacturing with internal quality controls and full lot traceability.

For the full technology explanation, see Core Technology. For validation status and analytical specifications, see Research & Analytical Performance.

Request OEM/ODM information

To scope an OEM, ODM, or private-label project, include the target market, analyte menu, analyzer preference, packaging/language requirements, and estimated quantity in your inquiry: