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HIV Rapid Test: Separate HIV-1 & HIV-2 Detection | IVDR Class D

Separate HIV-1 and HIV-2 Detection with Dedicated Result Lines in 15 Minutes: Why an IVDR-Class-D Rapid Test Belongs in Every Screening Portfolio Early HIV detection saves lives. The sooner a person knows their status, the sooner they can access life-saving antiretroviral therapy, reduce viral load to undetectable levels, and prevent onward transmission. For healthcare systems...

NEWSCEN IVD Solutions | IVDR & CE-Marked Self-Tests

NEWSCEN IVD Solutions bring together infectious disease diagnostics, clinical health testing and reproductive health self-testing for the European and international markets. Our portfolio includes an IVDR HIV test, HCV testing moving toward IVDR certification, and CE-marked IVDD self-tests for SF, FOB, LH, FSH and HCG. NEWSCEN IVD Solutions for a Changing European Diagnostic Market The...

FOB Test Kit: A Reliable Rapid Solution for Fecal Occult Blood Detection

Introduction Gastrointestinal (GI) bleeding can occur without obvious symptoms, making reliable detection methods important for early clinical evaluation and health management. NewScen One-Step Fecal Occult Blood (FOB) Diagnostic Kit provides a convenient and reliable solution for detecting human hemoglobin (Hb) in fecal samples. Based on advanced immunochromatographic technology, the test offers rapid results, simple operation,...

World Hepatitis Day 2026: Every Test Brings Us One Step Closer to Elimination

Every year on July 28, the world observes World Hepatitis Day, one of the World Health Organization’s official global health campaigns. The day unites governments, healthcare providers, laboratories, and diagnostic manufacturers in raising awareness about viral hepatitis and promoting early testing. Although hepatitis is preventable, treatable, and in many cases curable, millions of people continue...

Serum Ferritin Test Kit (SF) | Rapid Iron Deficiency Screening

Serum Ferritin Test Kit (SF) – Rapid Screening Solution for Early Detection of Iron Deficiency Empowering Early Iron Deficiency Detection with Reliable Point-of-Care Testing NEWSCEN Serum Ferritin Test Kit (SF) is a rapid point-of-care diagnostic solution designed for early detection of iron deficiency through semi-quantitative ferritin testing from finger blood samples. NEWSCEN Serum Ferritin Test...

NEWSCEN HIV (1+2) Antibody Rapid Test: Fully IVDR Class D Certified One-Stop Compliance Solution for EU Market

NEWSCEN HIV (1+2) Antibody Rapid Test:Introduction: 9 July IVDR Anniversary – Compliance Crisis Hits EU HIV Testing Market Every 9 July marks the important anniversary of the EU In Vitro Diagnostic Regulation (IVDR 2017/746). As the EU tightens supervision over high-risk Class D diagnostic reagents, numerous old IVDD certificates are expiring. Laboratories and distributors are...

MEDICA 2025 | NewScen Launches IVDR-Certified HIV Rapid Test — Unlocking New Growth Opportunities in the European IVD Market

Exhibition Overview From 17–20 November 2025, the MEDICA International Medical Trade Fair will once again take place in Düsseldorf, Germany under the theme “Meet Health, Future, People.”The exhibition continues to serve as a global platform for medical technology innovation, highlighting future-oriented healthcare solutions and industry development trends. Established in 1969, MEDICA is widely recognized as...

NewScen’s HIV IVDR CE Certification Application Progressing Steadily, Advancing Toward a New Stage of Global Compliance

  The HIV (1+2) Antibody Rapid Test by NEWSCEN (NewScen Coast Bio-Pharmaceutical Co., Ltd.) is expected to obtain the IVDR CE certification (Regulation EU 2017/746) officially in Q3 of 2025, issued by TÜV SÜD Product Service GmbH, a globally renowned third-party endorsement organization of the EU, in accordance with IVDR regulations.  It would be a significant milestone for NEWSCEN’s internationalization...