Breaking News in HIV Diagnostics!NEWSCEN Professional HIV (1+2) Tri-Line Rapid Test
World’s Only CE IVDR Class D Certified
MEDICA 2025
Join NEWSCEN at MEDICA 2025, one of the world’s most influential medical trade exhibitions, to explore our latest CE IVDR Class D HIV rapid testing solution and connect with global healthcare partners!
November 17–20, 2025
Düsseldorf, Germany
Hall 1 / G39-2
Book a meeting with us and get free product samples!
HIV (1+2) Antibody Rapid Test
100% Specificity & 100% Sensitivity
Ensures highly accurate detection, minimizing false results.
Tri-Line Differentiation Technology
Detects and differentiates HIV-1, HIV-2, and Dual Infection.
EARLY DETECTION
7 Days Post-Exposure
ULTRA-FAST
15 min to Result
ANYWHERE TESTING
No Instrument Required
GLOBAL-READY
4–30°C Storage
MULTI-SPECIMEN
WB / Serum / Plasma
TRUSTED PERFORMANCE
Gold Immunoassay Method
HCV Antibody Rapid Test
(Professional Use · CE IVDR Pending Certification)
Dual-Antigen Technology (Core + NS3)
CLINICALLY PROVEN PERFORMANCE
→ 99.76% Sensitivity (421 positives)
→ 100% Specificity (1700 negatives)
→ Stable across 6 major HCV genotypes
MULTI-SPECIMEN COMPATIBILITY
→ Whole blood / Serum / Plasma
→ 100% consistency with fingertip blood
RAPID RESULTS — 15 MINUTES
→ Simple workflow, no instrument required
→ Suitable for large-scale screening
GLOBAL-FRIENDLY STABILITY
→ Storage at 4–30°C
→ Proven reproducibility across sites
SF FOB LCG LH FSH
Anemia Iron Deficiency Test
FOB
Human Chorionic Gonadotropin (hCG) tests
Urine LH Ovulation Tests Cassette Kits For Ovulation
FSH
Certification You Need to Check
To meet global market requirements, NEWSCEN is fully certified with CE (IVDR), ISO 13485, FSC, DoC, and NMPA approvals.Click each certification to explore details.
| A CE Mark certification is required for marketing medical devices within the European Union. NEWSCEN’s HIV (1+2) Tri-Line Rapid Test has obtained CE IVDR Class D certification, meeting the EU’s highest standard for in-vitro diagnostic devices. | |
| CE (IVDR) | |
| ISO 13485:2016 is the international quality management system standard for medical devices, ensuring products and related services consistently meet customer and regulatory requirements. | |
| ISO 13485 | |
| The Free Sales Certificate confirms that NEWSCEN’s products are legally marketed and freely sold in the country of origin — a key document for export registration in many regions. | |
| FSC (Free Sales Certificate) | |
| The Declaration of Conformity is a formal statement by NEWSCEN declaring that its products comply with all relevant safety and performance requirements under applicable directives. | |
| DoC (Declaration of Conformity) | |
| NMPA, formerly CFDA, is the regulatory authority in China responsible for the registration, supervision, and quality management of medical devices and diagnostics. | |
| NMPA (China Registration) | |
ABOUT USSupplier to IVD Manufacturers with Over 22 Years Experience
NewScen Coast Bio-Pharmaceutical Co., Ltd. (NewScen), founded in 2003, as a way to address what they saw as an obvious need in In-vitro Diagnostic field in China, is an innovative and respected diagnostic reagent solutions distribution and marketing company that provides high-tech diagnostic reagent solutions specializing in microfluidics products, colloidal gold rapid tests, testing instrument, as well as OEM projects on uncut sheets.
BENEFITSWhy Choose Us
Listed Corporate
22⁺ Years
90⁺ Countries
300⁺ Employees
1000 ㎡ Factory
100⁺ Certificates
Your Full-Service Lab for Clinical Trials
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+86-22-25321648-846
NO. 65 Sixth Ave, TEDA Tianjin, 300457, P. R. China
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