{"id":3260,"date":"2026-08-27T20:53:30","date_gmt":"2026-08-27T19:53:30","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=3260"},"modified":"2026-08-27T21:52:51","modified_gmt":"2026-08-27T20:52:51","slug":"ivdr-class-d-sample-sets","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets\/","title":{"rendered":"IVDR Class D Sample Sets"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3260\" class=\"elementor elementor-3260\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8ed376 e-con e-atomic-element e-flexbox-base e-bd9909b \" data-id=\"d8ed376\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"d8ed376\" data-e-type=\"e-flexbox\" data-id=\"d8ed376\">\n    \t\t<div class=\"elementor-element elementor-element-81e2c05 elementor-widget elementor-widget-html\" data-id=\"81e2c05\" 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: ivdr-class-d-sample-sets\nSEO Title: IVDR Class D Sample Sets \u2014 HBV HCV HIV Compliance Panels | SeamlessBio\nMeta Description: Ready-to-use IVDR Class D sample sets for HBV, HCV and HIV validation per EU Regulation 2017\/746. Diagnostic sensitivity, specificity, self-test and matrix equivalence panels.\nFocus Keyword: IVDR Class D sample sets HBV HCV HIV\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        { \"@type\": \"ListItem\", \"position\": 4, \"name\": \"IVDR Class D Sample Sets\", \"item\": \"https:\/\/seamlessbio.de\/ivdr-class-d-sample-sets\/\" }\n      ]\n    },\n    {\n      \"@type\": \"Product\",\n      \"name\": \"IVDR Class D Sample Sets \u2014 HBV, HCV, HIV\",\n      \"brand\": { \"@type\": \"Brand\", \"name\": \"SeamlessBio\" },\n      \"description\": \"Ready-to-use compliance panels for HBV, HCV and HIV validation per EU Regulation 2017\/746 and CTS 2009\/108\/EC \u2014 diagnostic sensitivity, specificity, self-test and matrix equivalence sets.\",\n      \"offers\": { \"@type\": \"Offer\", \"url\": \"https:\/\/seamlessbio.de\/contact\/\", \"availability\": \"https:\/\/schema.org\/InStock\", \"priceCurrency\": \"EUR\" }\n    },\n    {\n      \"@type\": \"FAQPage\",\n      \"mainEntity\": [\n        {\n          \"@type\": \"Question\",\n          \"name\": \"Which IVDR Class D panels do you supply?\",\n          \"acceptedAnswer\": { \"@type\": \"Answer\", \"text\": \"We supply diagnostic sensitivity panels (HBV, HCV, HIV-1, HIV-2), diagnostic specificity panels (unselected blood donors, hospitalised patients), interference and cross-reactivity panels, whole system failure rate panels, self-test validation sets per Annex III\/V\/VI table 6, and matrix equivalence sets.\" }\n        },\n        {\n          \"@type\": \"Question\",\n          \"name\": \"Are the panels CTS-compliant for IVDR submission?\",\n          \"acceptedAnswer\": { \"@type\": \"Answer\", \"text\": \"Yes. Panels are specifically assembled to meet the requirements of the Common Technical Specifications 2009\/108\/EC referenced in IVDR 2017\/746 for Class D IVDs (HBV, HCV, HIV). Each panel is referenced to the specific Annex and table number of the CTS. Full IVDR documentation packages are available on request.\" }\n        },\n        {\n          \"@type\": \"Question\",\n          \"name\": \"What documentation is included with each panel?\",\n          \"acceptedAnswer\": { \"@type\": \"Answer\", \"text\": \"Standard documentation includes: IRB\/ethics clearance certificate, donor informed consent framework documentation, confirmed diagnostic test results per sample, standard infectious disease screening (HIV I\/II Ab, HBsAg, HCV Ab), storage and handling instructions, and ISO 13485 certified quality system documentation from in.vent Diagnostica GmbH. Extended IVDR documentation packages are available on request.\" }\n        }\n      ]\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  <a href=\"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\">Human Biomaterials &amp; IVD<\/a><span>\/<\/span>\n  <strong>IVDR Class D Sample Sets<\/strong>\n<\/nav>\n\n<div class=\"sb-hsm-hero\">\n  <div class=\"sb-hsm-hero-text\">\n    <span class=\"sb-hsm-eyebrow\">CTS 2009\/108\/EC \u00b7 IVDR 2017\/746 \u00b7 ISO 13485 Source<\/span>\n    <h1>IVDR Class D Sample Sets<\/h1>\n    <p>Ready-to-use compliance panels for HBV, HCV and HIV validation under EU Regulation 2017\/746. Each panel is referenced to the specific Annex and table of the Common Technical Specifications (CTS 2009\/108\/EC) \u2014 covering diagnostic sensitivity, specificity, self-test validation and matrix equivalence studies.<\/p>\n    <div class=\"sb-hsm-hero-tags\">\n      <span>HBV Panels<\/span><span>HCV Panels<\/span><span>HIV-1\/2 Panels<\/span>\n      <span>Blood Donor Specificity<\/span><span>Self-Test Validation<\/span><span>Matrix Equivalence<\/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?subject=IVDR%20Class%20D%20Panels\" 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;\">IVDR Class D Panels<\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-facts\">\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">CTS<\/span><span>Each panel referenced to specific Annex and table of CTS 2009\/108\/EC<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">ISO 13485<\/span><span>Source partner in.vent Diagnostica GmbH \u2014 certified quality system<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">Native<\/span><span>Native human biomaterial \u2014 no additives, no reconstitution<\/span><\/div>\n  <div class=\"sb-hsm-fact\"><span class=\"sb-hsm-fact-n\">48h<\/span><span>Quote turnaround with availability confirmation<\/span><\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>HBV \u2014 Hepatitis B Virus Panels<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>CTS Reference<\/th><th>Description<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>HBV Anti-HBs<\/td><td>Annex VI, table 4<\/td><td>HBV naturally infected, positive specimens<\/td><td>100<\/td><\/tr>\n        <tr><td>HBV DNA<\/td><td>Annex VI, table 5<\/td><td>HBV DNA positive<\/td><td>100<\/td><\/tr>\n        <tr><td>HBV<\/td><td>Annex VI, table 4<\/td><td>HBV positive<\/td><td>200<\/td><\/tr>\n        <tr><td>HBV HBsAg<\/td><td>Annex VI, table 3<\/td><td>HBsAg positive<\/td><td>300<\/td><\/tr>\n        <tr><td>HBV Anti-HBc HBsAg<\/td><td>Annex VI, table 2<\/td><td>Anti-HBc + HBsAg positive<\/td><td>400<\/td><\/tr>\n        <tr><td>HBV-Vaccinated<\/td><td>Annex VI, table 4<\/td><td>HBV vaccinated donors<\/td><td>100<\/td><\/tr>\n        <tr><td>HBV incl. fresh<\/td><td>Annex VI, table 1<\/td><td>HBV positive incl. 25 same-day fresh samples<\/td><td>400<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>HCV \u2014 Hepatitis C Virus Panels<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>CTS Reference<\/th><th>Description<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>HCV<\/td><td>Annex V, table 5<\/td><td>HCV positive<\/td><td>100<\/td><\/tr>\n        <tr><td>HCV<\/td><td>Annex V, table 3<\/td><td>HCV positive<\/td><td>300<\/td><\/tr>\n        <tr><td>HCV<\/td><td>Annex V, table 2<\/td><td>HCV positive<\/td><td>400<\/td><\/tr>\n        <tr><td>HCV incl. fresh<\/td><td>Annex V, table 1<\/td><td>HCV positive incl. 25 same-day fresh samples<\/td><td>400<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>HIV-1 \/ HIV-2 Panels<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>CTS Reference<\/th><th>Description<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>HIV-1<\/td><td>Annex III, table 5<\/td><td>HIV-1 positive<\/td><td>100<\/td><\/tr>\n        <tr><td>HIV-1<\/td><td>Annex III, table 3<\/td><td>HIV-1 positive<\/td><td>200<\/td><\/tr>\n        <tr><td>HIV-1<\/td><td>Annex III, table 1, 2<\/td><td>HIV-1 positive<\/td><td>400<\/td><\/tr>\n        <tr><td>HIV-1 Ag<\/td><td>Annex III, table 4<\/td><td>HIV-1 Antigen positive<\/td><td>50<\/td><\/tr>\n        <tr><td>HIV-2<\/td><td>Annex III, table 1, 2, 5<\/td><td>HIV-2 positive<\/td><td>100<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Diagnostic Specificity \u2014 Blood Donors<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>CTS Reference<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>Blood Donors<\/td><td>Annex III, V, VI \u2014 unselected blood donors<\/td><td>5,000<\/td><\/tr>\n        <tr><td>Blood Donors<\/td><td>Annex III, V \u2014 table 2<\/td><td>1,000<\/td><\/tr>\n        <tr><td>Blood Donors<\/td><td>Annex III, V, VI \u2014 table 5<\/td><td>500<\/td><\/tr>\n        <tr><td>Blood Donors incl. Clinical<\/td><td>Annex VI, table 4 \u2014 480 donors + 20 hospitalised<\/td><td>500<\/td><\/tr>\n        <tr><td>Blood Donors<\/td><td>Annex III, V, VI \u2014 table 4<\/td><td>200<\/td><\/tr>\n        <tr><td>Blood Donors<\/td><td>Annex III, V, VI \u2014 table 5<\/td><td>100<\/td><\/tr>\n        <tr><td>Hospitalised Donors<\/td><td>Annex III, V, VI \u2014 table 1, 2, 4<\/td><td>200<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Interference &amp; Cross-Reactivity Panels<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>Description<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>General Interference Panel<\/td><td>16 standard interferents for Class D specificity validation<\/td><td>52<\/td><\/tr>\n        <tr><td>Vaccination Panel<\/td><td>5 common pathogen vaccinations<\/td><td>15<\/td><\/tr>\n        <tr><td>Inflammation Panel<\/td><td>4 inflammatory markers<\/td><td>12<\/td><\/tr>\n        <tr><td>Hepatitis Panel<\/td><td>4 serological markers against hepatitis viruses<\/td><td>12<\/td><\/tr>\n        <tr><td>Herpes Panel<\/td><td>5 serological markers against herpes viruses<\/td><td>15<\/td><\/tr>\n        <tr><td>Microbial Pathogen Panel<\/td><td>5 bacterial and eukaryotic pathogens<\/td><td>15<\/td><\/tr>\n        <tr><td>Respiratory Pathogen Panel<\/td><td>4 respiratory pathogens<\/td><td>12<\/td><\/tr>\n        <tr><td>Cross-reactive incl. pregnant<\/td><td>Annex III, V, VI \u2014 cross-reacting specimens<\/td><td>100<\/td><\/tr>\n        <tr><td>Cross-reactive pregnant<\/td><td>Annex III, V, VI \u2014 pregnant donors<\/td><td>200<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Self-Test Validation (Lay Use)<\/h2>\n  <p class=\"sb-hsm-intro\">Per CTS 2009\/108\/EC Annex III, V, VI table 6 \u2014 for self-test IVDs intended for lay use.<\/p>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Panel<\/th><th>CTS Reference<\/th><th>n<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>Self-Test Known Positive HBV<\/td><td>Annex VI, table 6<\/td><td>200 participants<\/td><\/tr>\n        <tr><td>Self-Test Known Positive HCV<\/td><td>Annex V, table 6<\/td><td>200 participants<\/td><\/tr>\n        <tr><td>Self-Test Known Positive HIV<\/td><td>Annex III, table 6<\/td><td>200 participants<\/td><\/tr>\n        <tr><td>Self-Test High Risk<\/td><td>Annex III, V, VI, table 6<\/td><td>200 participants<\/td><\/tr>\n        <tr><td>Self-Test Unknown Status<\/td><td>Annex III, V, VI, table 6<\/td><td>400 participants<\/td><\/tr>\n        <tr><td>Self-Test Result Interpretation<\/td><td>Annex III, V, VI, table 6<\/td><td>100 participants<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Matrix Equivalence Sets<\/h2>\n  <div class=\"sb-hsm-comparison\">\n    <table class=\"sb-hsm-cmp\">\n      <thead><tr><th>Set<\/th><th>CTS Reference<\/th><th>Composition<\/th><\/tr><\/thead>\n      <tbody>\n        <tr><td>Matrix Equivalency HBV<\/td><td>Annex I, General Common Specification, part I<\/td><td>25 positive + 25 negative<\/td><\/tr>\n        <tr><td>Matrix Equivalency HCV<\/td><td>Annex I<\/td><td>25 positive + 25 negative<\/td><\/tr>\n        <tr><td>Matrix Equivalency HIV-1<\/td><td>Annex I<\/td><td>25 positive + 25 negative<\/td><\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-alt\">\n  <h2>Documentation Included with Every Panel<\/h2>\n  <div class=\"sb-hsm-app-grid\">\n    <div class=\"sb-hsm-app\">\n      <h3>Ethics &amp; Consent<\/h3>\n      <p>IRB \/ Ethics Board clearance certificate and donor informed consent framework documentation included as standard with every panel.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>Diagnostic Confirmation<\/h3>\n      <p>Confirmed diagnostic test results per individual sample. Standard infectious disease screening (HIV I\/II Ab, HBsAg, HCV Ab) on all donors.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-app\">\n      <h3>IVDR Package (on request)<\/h3>\n      <p>Extended IVDR documentation package for Class D submission \u2014 including ISO 13485 quality certificate, IVDR-specific documentation and regulatory support.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\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 panels CTS-compliant for IVDR Class D submission?<\/h3>\n      <p>Yes. Each panel is specifically assembled to meet the requirements of the Common Technical Specifications 2009\/108\/EC referenced in IVDR 2017\/746 for Class D IVDs \u2014 HBV, HCV, and HIV. Panels are referenced to the specific Annex and table number of the CTS so you can map them directly to your technical file.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>Can you supply fresh samples (same-day collection)?<\/h3>\n      <p>Yes \u2014 specific panels include same-day fresh samples (25 fresh per panel for HBV incl. fresh and HCV incl. fresh). Fresh sample supply requires advance coordination and scheduling \u2014 contact us to plan your timeline.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>What is the typical lead time for panels?<\/h3>\n      <p>Quote within 48 hours. Standard panels from stock: 1\u20133 weeks. Larger panels (&gt;500 samples) or custom compositions: 4\u20138 weeks depending on availability. Advance coordination is recommended for Class D submission timelines.<\/p>\n    <\/div>\n    <div class=\"sb-hsm-faq\">\n      <h3>Are the panels suitable for self-test (lay use) device validation?<\/h3>\n      <p>Yes. We supply self-test validation sets per CTS Annex III, V, VI table 6 \u2014 covering known positive, high-risk, unknown-status, and result-interpretation cohorts, with the participant numbers required by the CTS for lay-use device validation.<\/p>\n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-section\">\n  <h2>Related Products<\/h2>\n  <div class=\"sb-hsm-related\">\n    <a href=\"https:\/\/seamlessbio.de\/disease-state-serum-panels\/\" class=\"sb-hsm-rel\">\n      <h3>Disease State Serum Panels<\/h3>\n      <p>Cross-reactivity and interference challenge materials \u2014 autoimmune, infectious, thyroid, allergy and more.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/human-quality-controls-standard-materials\/\" class=\"sb-hsm-rel\">\n      <h3>Quality Controls &amp; Standards<\/h3>\n      <p>Native human-origin IQC and EQA controls across all major diagnostic areas.<\/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 how it is used in IVD development.<\/p>\n    <\/a>\n    <a href=\"https:\/\/seamlessbio.de\/human-biomaterials-ivd\/\" class=\"sb-hsm-rel\">\n      <h3>Human Biomaterials &amp; IVD \u2014 Overview<\/h3>\n      <p>Full portfolio overview \u2014 all product categories at a glance.<\/p>\n    <\/a>\n  <\/div>\n<\/div>\n\n<div class=\"sb-hsm-cta\">\n  <h2>Request IVDR Class D Panels \u2014 Quote<\/h2>\n  <p>Tell us which panels you need and your submission timeline \u2014 we respond within 48 hours with availability and pricing.<\/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=IVDR%20Class%20D%20Panels%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 span{color:#ccc}\n.sb-hsm-hero{display:grid;grid-template-columns:1.2fr 0.8fr;gap:48px;align-items:center;background:linear-gradient(135deg,#0d9490 0%,#18b7b2 60%,#1ec8c2 100%);border-radius:30px;padding:56px 52px;margin-bottom:48px;color:#fff}\n.sb-hsm-eyebrow{display:inline-block;font-size:12px;font-weight:700;letter-spacing:.12em;text-transform:uppercase;background:rgba(255,255,255,.2);border-radius:20px;padding:4px 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