{"id":3292,"date":"2026-08-27T21:47:46","date_gmt":"2026-08-27T20:47:46","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=3292"},"modified":"2026-08-27T21:51:36","modified_gmt":"2026-08-27T20:51:36","slug":"human-biomaterials-ivd","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/human-biomaterials-ivd\/","title":{"rendered":"Produktseite Human IVD Biomaterials"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3292\" class=\"elementor elementor-3292\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b6e3bd2 e-con e-atomic-element e-flexbox-base e-5466a39 \" data-id=\"b6e3bd2\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"b6e3bd2\" data-e-type=\"e-flexbox\" data-id=\"b6e3bd2\">\n    \t\t<div class=\"elementor-element elementor-element-6b80938 elementor-widget elementor-widget-html\" data-id=\"6b80938\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<!--\nWORDPRESS PAGE \u2014 GUTENBERG \"BENUTZERDEFINIERTES HTML\" BLOCK\nSlug: human-biomaterials-ivd\nSEO Title: Human Biomaterials & IVD \u2014 Diagnostic Sample Sets | SeamlessBio\nMeta Description: Human biomaterials for IVD development \u2014 IVDR Class D panels, disease state serum, quality controls, fertility materials and human tissues. ISO 13485 certified source.\nFocus Keyword: human biomaterials IVD supplier Europe\nMeta Robots: index, follow\n-->\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \"@type\": \"BreadcrumbList\",\n      \"itemListElement\": [\n        { \"@type\": \"ListItem\", \"position\": 1, \"name\": \"Home\", \"item\": \"https:\/\/seamlessbio.de\/\" },\n        { \"@type\": \"ListItem\", \"position\": 2, \"name\": \"Products\", \"item\": \"https:\/\/seamlessbio.de\/products\/\" },\n        { \"@type\": \"ListItem\", \"position\": 3, \"name\": \"Human Biomaterials & IVD\", \"item\": \"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\" }\n      ]\n    },\n    {\n      \"@type\": \"CollectionPage\",\n      \"name\": \"Human Biomaterials & IVD\",\n      \"description\": \"Human biomaterials for in vitro diagnostic development \u2014 IVDR Class D compliance panels, disease state serum, quality controls, fertility materials, human tissues and speciality matrices. ISO 13485 certified source.\",\n      \"url\": \"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\",\n      \"provider\": { \"@type\": \"Organization\", \"name\": \"SeamlessBio\" }\n    }\n  ]\n}\n<\/script>\n\n<section class=\"sb-hsm-page\">\n<div class=\"sb-hsm-container\">\n\n<nav class=\"sb-hsm-bc\">\n  <a href=\"https:\/\/seamlessbio.de\/\">Home<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/products\/\">Products<\/a><span>\/<\/span>\n  <strong>Human Biomaterials &amp; IVD<\/strong>\n<\/nav>\n\n<!-- HERO -->\n<div class=\"sb-hsm-hero\">\n  <div class=\"sb-hsm-hero-text\">\n    <span class=\"sb-hsm-eyebrow\">ISO 13485 Certified Source \u00b7 IVDR 2017\/746 \u00b7 EU Donor Origin<\/span>\n    <h1>Human Biomaterials &amp; IVD<\/h1>\n    <p>Native human serum, plasma, tissue and speciality matrices for the complete IVD value chain \u2014 from early assay development through IVDR Class D regulatory submission. All materials collected under IRB-cleared ethical framework with full donor documentation and traceability.<\/p>\n    <div class=\"sb-hsm-hero-tags\">\n      <span>IVDR Class D Panels<\/span>\n      <span>Disease State Serum<\/span>\n      <span>Quality Controls<\/span>\n      <span>Fertility Materials<\/span>\n      <span>Human Tissues<\/span>\n    <\/div>\n    <div class=\"sb-hsm-hero-btns\">\n      <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-btn\">Request Quote<\/a>\n      <a href=\"mailto:info@seamlessbio.de\" class=\"sb-hsm-btn-outline\">info@seamlessbio.de<\/a>\n    <\/div>\n  <\/div>\n  <div class=\"sb-hsm-hero-image\">\n    <div class=\"sb-hsm-img-fallback\" style=\"display:flex;\">Human Biomaterials &amp; IVD<\/div>\n  <\/div>\n<\/div>\n\n<!-- KEY FACTS -->\n<div class=\"sb-hsm-facts\">\n  <div class=\"sb-hsm-fact\">\n    <span class=\"sb-hsm-fact-n\">ISO 13485<\/span>\n    <span>Certified quality system \u2014 source partner in.vent Diagnostica GmbH<\/span>\n  <\/div>\n  <div class=\"sb-hsm-fact\">\n    <span class=\"sb-hsm-fact-n\">IVDR<\/span>\n    <span>Panels designed per EU Regulation 2017\/746 &amp; CTS 2009\/108\/EC<\/span>\n  <\/div>\n  <div class=\"sb-hsm-fact\">\n    <span class=\"sb-hsm-fact-n\">200+<\/span>\n    <span>Disease state analytes and conditions available<\/span>\n  <\/div>\n  <div class=\"sb-hsm-fact\">\n    <span class=\"sb-hsm-fact-n\">48h<\/span>\n    <span>Quote turnaround \u2014 direct access, no distributor chain<\/span>\n  <\/div>\n<\/div>\n\n<!-- PRODUCT CATEGORIES -->\n<div class=\"sb-hsm-section\">\n  <h2>Product Categories<\/h2>\n  <div class=\"sb-hsm-overview-grid\">\n\n    <a href=\"https:\/\/seamlessbio.de\/ivdr-class-d-sample-sets\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\ud83e\uddeb<\/span>\n      <h3>IVDR Class D Sample Sets<\/h3>\n      <p>Ready-to-use compliance panels for HBV, HCV and HIV validation per CTS 2009\/108\/EC \u2014 diagnostic sensitivity, specificity, self-test and matrix equivalence sets.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">View panels \u2192<\/span>\n    <\/a>\n\n    <a href=\"https:\/\/seamlessbio.de\/disease-state-serum-panels\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\ud83e\ude78<\/span>\n      <h3>Disease State Serum Panels<\/h3>\n      <p>Human serum and plasma from confirmed-positive donors \u2014 autoimmune, infectious disease, thyroid, allergy, diabetes, oncology, inflammation and drugs of abuse.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">View portfolio \u2192<\/span>\n    <\/a>\n\n    <a href=\"https:\/\/seamlessbio.de\/human-quality-controls-standard-materials\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\u2705<\/span>\n      <h3>Quality Controls &amp; Standards<\/h3>\n      <p>Native human-origin quality controls for IQC, EQA and proficiency testing across autoimmunity, infectiology, endocrinology, gastroenterology, oncology and allergy.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">View controls \u2192<\/span>\n    <\/a>\n\n    <a href=\"https:\/\/seamlessbio.de\/fertility-pregnancy-serum-materials\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\ud83d\udd2c<\/span>\n      <h3>Fertility &amp; Pregnancy Materials<\/h3>\n      <p>Trimester-specific pools, hCG, AMH, FSH, LH, progesterone, preeclampsia and gestational diabetes serum \u2014 for IVD assay development and calibration.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">View materials \u2192<\/span>\n    <\/a>\n\n    <a href=\"https:\/\/seamlessbio.de\/human-tissues-specialities\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\ud83e\uddec<\/span>\n      <h3>Human Tissues &amp; Specialities<\/h3>\n      <p>Fresh frozen and FFPE tumour tissue, CSF, IgG-depleted serum, steroid-depleted serum, blood cell lysate, anticoagulant panels and preanalytical matrices.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">View specialities \u2192<\/span>\n    <\/a>\n\n    <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-ov-card\">\n      <span class=\"sb-hsm-ov-icon\">\ud83d\udccb<\/span>\n      <h3>Custom Panels &amp; Projects<\/h3>\n      <p>Bespoke collections from defined donor cohorts \u2014 specific titres, consecutive donations, co-morbidity panels, clinical study samples. Describe your need and we respond within 48 hours.<\/p>\n      <span class=\"sb-hsm-ov-card-cta\">Discuss your project \u2192<\/span>\n    <\/a>\n\n  <\/div>\n<\/div>\n\n<!-- WHO USES THIS -->\n<div class=\"sb-hsm-alt\">\n  <h2>Who Uses SeamlessBio Human Biomaterials<\/h2>\n  <div class=\"sb-hsm-app-grid\">\n    <div class=\"sb-hsm-app\">\n      <h3>IVD Manufacturers<\/h3>\n      <p>Performance evaluation, cross-reactivity testing, IVDR Class D submission panels, calibrator and control production \u2014 Roche, Siemens, Abbott, DiaSorin, Euroimmun level applications.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>CROs &amp; Clinical Research<\/h3>\n      <p>Reference sample banks, clinical performance studies, retrospective cohorts, biobank-grade collection under GCP-aligned ethical framework.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Biomarker &amp; Assay R&amp;D<\/h3>\n      <p>Target validation, antibody screening, assay format comparison, matrix interference studies \u2014 at research scale with full donor documentation.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<!-- WHY SEAMLESSBIO -->\n<div class=\"sb-hsm-section\">\n  <h2>Why SeamlessBio for Human Biomaterials<\/h2>\n  <div class=\"sb-hsm-two-col\">\n    <div class=\"sb-hsm-text\">\n      <h3>ISO 13485 Certified Source<\/h3>\n      <p>All human biomaterials are sourced from in.vent Diagnostica GmbH (Hennigsdorf, Germany) \u2014 ISO 13485 and ISO 9001 certified, with an established ethical framework, IRB clearance, and donor informed consent documentation across all material categories.<\/p>\n      <h3>IVDR-Ready Documentation<\/h3>\n      <p>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.<\/p>\n      <h3>Native Human Material<\/h3>\n      <p>All materials consist of native human biomaterial with no additives \u2014 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.<\/p>\n    <\/div>\n    <div>\n      <div class=\"sb-hsm-comparison\">\n        <h3>Documentation Included<\/h3>\n        <table class=\"sb-hsm-cmp\">\n          <thead><tr><th>Document<\/th><th>Standard<\/th><th>On Request<\/th><\/tr><\/thead>\n          <tbody>\n            <tr><td>Certificate of Analysis<\/td><td>\u2705<\/td><td>\u2014<\/td><\/tr>\n            <tr><td>Confirmed diagnostic results<\/td><td>\u2705<\/td><td>\u2014<\/td><\/tr>\n            <tr><td>Infectious disease screening (HIV\/HBV\/HCV)<\/td><td>\u2705<\/td><td>\u2014<\/td><\/tr>\n            <tr><td>IRB\/Ethics clearance certificate<\/td><td>\u2705<\/td><td>\u2014<\/td><\/tr>\n            <tr><td>Donor informed consent framework<\/td><td>\u2705<\/td><td>\u2014<\/td><\/tr>\n            <tr><td>Extended IVDR documentation package<\/td><td>\u2014<\/td><td>\u2705<\/td><\/tr>\n            <tr><td>Individual donor traceability<\/td><td>\u2014<\/td><td>\u2705<\/td><\/tr>\n            <tr><td>CE-IVD marking documentation<\/td><td>\u2014<\/td><td>\u2705<\/td><\/tr>\n          <\/tbody>\n        <\/table>\n      <\/div>\n      <div class=\"sb-hsm-ref-box\" style=\"margin-top:16px;\">\n        <h3>Quote within 48 hours<\/h3>\n        <p>Describe your analyte, matrix, volume and application \u2014 we respond within 48 hours with availability, pricing, and relevant documentation. No minimum order quantity for most materials.<\/p>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/div>\n\n<!-- FAQ -->\n<div class=\"sb-hsm-section\">\n  <h2>Frequently Asked Questions<\/h2>\n  <div class=\"sb-hsm-faqs\">\n    <div class=\"sb-hsm-faq\">\n      <h3>Are the materials suitable for CE marking under IVDR 2017\/746?<\/h3>\n      <p>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.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>What is the minimum order quantity?<\/h3>\n      <p>Most disease state sera are available from single donations (150\u2013850 mL). Quality controls and panels have specific minimum quantities that vary by product. Contact us with your specific requirement \u2014 we will confirm availability and minimum quantities within 48 hours.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>Are these materials suitable for use as IVD calibrators?<\/h3>\n      <p>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.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>Can you source specific donor cohorts or co-morbidity combinations?<\/h3>\n      <p>Yes \u2014 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.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<!-- RELATED -->\n<div class=\"sb-hsm-section\">\n  <h2>Related Products<\/h2>\n  <div class=\"sb-hsm-related\">\n    <a href=\"https:\/\/seamlessbio.de\/products\/human-sera-plasma-and-more\/\" class=\"sb-hsm-rel\">\n      <h3>Human Serum &amp; Plasma<\/h3>\n      <p>AB serum, OTC serum, male-only pools, hPL \u2014 for cell culture, ATMP and immunology.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/what-is-disease-state-serum\/\" class=\"sb-hsm-rel\">\n      <h3>What is Disease State Serum?<\/h3>\n      <p>Definition, applications and when you need it for IVD development.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/human-serum-supplier-europe\/\" class=\"sb-hsm-rel\">\n      <h3>Human Serum Supplier Europe<\/h3>\n      <p>Comparison of European human serum suppliers \u2014 what to look for.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-rel\">\n      <h3>Request a Quote<\/h3>\n      <p>Tell us your analyte and application \u2014 response within 48 hours.<\/p>\n    <\/a>\n  <\/div>\n<\/div>\n\n<!-- CTA -->\n<div class=\"sb-hsm-cta\">\n  <h2>Request Human Biomaterials \u2014 Quote or Sample<\/h2>\n  <p>ISO 13485 certified source. IVDR documentation available. Native human material. 48-hour quote turnaround.<\/p>\n  <div class=\"sb-hsm-cta-btns\">\n    <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"sb-hsm-btn-w\">Contact Us<\/a>\n    <a href=\"mailto:info@seamlessbio.de?subject=Human%20Biomaterials%20Quote\" class=\"sb-hsm-btn-o\">info@seamlessbio.de<\/a>\n  <\/div>\n  <p class=\"sb-hsm-ruo\">For research use only unless stated otherwise.<\/p>\n<\/div>\n\n<\/div>\n<\/section>\n\n<style>\n.sb-hsm-page,.sb-hsm-page *,.sb-hsm-page *::before,.sb-hsm-page *::after{box-sizing:border-box}\n.sb-hsm-page{font-family:Arial,sans-serif;color:#1a1a1a;background:#fff;padding:60px 32px 90px}\n.sb-hsm-container{max-width:1200px;margin:0 auto}\n.sb-hsm-bc{display:flex;flex-wrap:wrap;gap:6px;align-items:center;font-size:13px;color:#888;margin-bottom:28px}\n.sb-hsm-bc a{color:#18b7b2!important;text-decoration:none!important;font-weight:600}\n.sb-hsm-bc strong{color:#111}\n.sb-hsm-bc 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