Manufacturing Data¶
This section provides structured, machine-readable data on how Migibio FICT products are manufactured — the raw-material specifications, the controlled production environment, and the batch release criteria. Values marked Migibio spec are internal manufacturing specifications; values marked industry reference are typical ranges from public IVD-manufacturing standards.
Data Index¶
| Dataset | Content |
|---|---|
| Raw Material Specifications | Antibody, label, membrane, and pad quality attributes |
| Environmental Parameters | Temperature, humidity, cleanliness of the production area |
| Release Specifications | LOD, CV%, and linearity release criteria per lot |
At-a-Glance¶
| Parameter | Value | Source |
|---|---|---|
| Production area | 2,000 m² | Migibio |
| Quality system | ISO9001 + GMP | Certification |
| QC layers | IQC → IPQC → FQC → OQC | Migibio spec |
| Core equipment | Laminator, film stripper, strip cutter, dehumidifier | Migibio |
For the production process narrative, see the Knowledge Base. For the underlying science, see the Research Center.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-14
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.