Human Biomaterials & IVD
Native human serum, plasma, tissue and speciality matrices for the complete IVD value chain — from early assay development through IVDR Class D regulatory submission. All materials collected under IRB-cleared ethical framework with full donor documentation and traceability.
Produktkategorien
IVDR Class D Sample Sets
Ready-to-use compliance panels for HBV, HCV and HIV validation per CTS 2009/108/EC — diagnostic sensitivity, specificity, self-test and matrix equivalence sets.
View panels →Disease State Serum Panels
Human serum and plasma from confirmed-positive donors — autoimmune, infectious disease, thyroid, allergy, diabetes, oncology, inflammation and drugs of abuse.
View portfolio →Quality Controls & Standards
Native human-origin quality controls for IQC, EQA and proficiency testing across autoimmunity, infectiology, endocrinology, gastroenterology, oncology and allergy.
View controls →Fertility & Pregnancy Materials
Trimester-specific pools, hCG, AMH, FSH, LH, progesterone, preeclampsia and gestational diabetes serum — for IVD assay development and calibration.
View materials →Human Tissues & Specialities
Fresh frozen and FFPE tumour tissue, CSF, IgG-depleted serum, steroid-depleted serum, blood cell lysate, anticoagulant panels and preanalytical matrices.
View specialities →Custom Panels & Projects
Bespoke collections from defined donor cohorts — specific titres, consecutive donations, co-morbidity panels, clinical study samples. Describe your need and we respond within 48 hours.
Discuss your project →Who Uses SeamlessBio Human Biomaterials
IVD Manufacturers
Performance evaluation, cross-reactivity testing, IVDR Class D submission panels, calibrator and control production — Roche, Siemens, Abbott, DiaSorin, Euroimmun level applications.
CROs & Clinical Research
Reference sample banks, clinical performance studies, retrospective cohorts, biobank-grade collection under GCP-aligned ethical framework.
Biomarker & Assay R&D
Target validation, antibody screening, assay format comparison, matrix interference studies — at research scale with full donor documentation.
Why SeamlessBio for Human Biomaterials
ISO 13485 Certified Source
All human biomaterials are sourced from in.vent Diagnostica GmbH (Hennigsdorf, Germany) — ISO 13485 and ISO 9001 certified, with an established ethical framework, IRB clearance, and donor informed consent documentation across all material categories.
IVDR-Ready Documentation
Panels are designed and assembled to generate the clinical data required under EU Regulation 2017/746 and the Common Technical Specifications (CTS 2009/108/EC). IVDR documentation packages available on request for Class D submissions.
Native Human Material
All materials consist of native human biomaterial with no additives — as identical to patient samples as possible. This is the critical difference for assay matrix matching: spiked or reconstituted materials behave differently from native patient samples in immunoassay formats.
Documentation Included
| Dokument | Standard | On Request |
|---|---|---|
| Analysezertifikat | ✅ | — |
| Confirmed diagnostic results | ✅ | — |
| Infectious disease screening (HIV/HBV/HCV) | ✅ | — |
| IRB/Ethics clearance certificate | ✅ | — |
| Donor informed consent framework | ✅ | — |
| Extended IVDR documentation package | — | ✅ |
| Individual donor traceability | — | ✅ |
| CE-IVD marking documentation | — | ✅ |
Quote within 48 hours
Describe your analyte, matrix, volume and application — we respond within 48 hours with availability, pricing, and relevant documentation. No minimum order quantity for most materials.
Häufig gestellte Fragen
Are the materials suitable for CE marking under IVDR 2017/746?
Yes. The IVDR Class D sample sets are specifically designed and assembled to generate the clinical data required under EU Regulation 2017/746 and the Common Technical Specifications (CTS 2009/108/EC) for HBV, HCV and HIV diagnostics. Full IVDR documentation packages are available on request.
Wie hoch ist die Mindestbestellmenge?
Most disease state sera are available from single donations (150–850 mL). Quality controls and panels have specific minimum quantities that vary by product. Contact us with your specific requirement — we will confirm availability and minimum quantities within 48 hours.
Are these materials suitable for use as IVD calibrators?
The materials are native human biomaterial and can serve as the basis for calibrator production. They are supplied as research-use materials unless specifically labelled as CE-certified controls (In.QualiCheck range). For IVD calibrator use, additional characterisation and validation by the IVD manufacturer is required.
Can you source specific donor cohorts or co-morbidity combinations?
Yes — custom collections from defined donor cohorts are possible, including specific titres, co-morbidity combinations, consecutive donations from the same donor, or prospective collection under a defined protocol. Contact us to discuss your project requirements.
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Request Human Biomaterials — Quote or Sample
ISO 13485 certified source. IVDR documentation available. Native human material. 48-hour quote turnaround.
For research use only unless stated otherwise.
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