Glossary Term
A manufacturer declaration that an in vitro diagnostic complies with applicable EU legislation (the IVDR since May 2022). CE-IVD indicates regulatory conformance, not a statement of clinical superiority; buyers still review performance claims and intended use.
Regulatory Definitions
Company
established in 1974. We develop, manufacture, and distribute reliable and fast CE marked diagnostic tests for point of care. Our aim is to aid global
Manufacturer
Product
Allplex™ GI Panels is catalogued from public product materials published by Seegene. Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
Allplex™ Respiratory Panels is catalogued from public product materials published by Seegene. Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
Allplex™ STI Panels is catalogued from public product materials published by Seegene. Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
ApoE/SLCO1B1 Gene Polymorphism Detection Kit is catalogued from public product materials published by Tianlong (天隆科技). Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
Chlamydia trachomatis and Ureaplasma urealyticum nucleic acid detection kit is catalogued from public product materials published by BGI Genomics Co., Ltd. Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
Diarrhea Virus (5 types) Nucleic Acid Detection Kit is catalogued from public product materials published by Tianlong (天隆科技). Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
EX-48 Automatic Nucleic Acid Extractor is catalogued from public product materials published by BGI Genomics Co., Ltd. Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Sample Preparation
Company
with State of the Art Manufacturing Facilities at Parwanoo the Foot hills of the Legend Himalayas. Majority of our assays are CE marked. Quality assurance
Manufacturer
Product
HBV DNA Quantitative Detection Kit is catalogued from public product materials published by Tianlong (天隆科技). Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays
Product
Influenza A/B Virus RNA Detection Kit is catalogued from public product materials published by Tianlong (天隆科技). Availability: not published on this record. Regulatory status is manufacturer-reported and has not been independently verified. Confirm intended use, compatibility and local registration against official documentation before procurement.
Molecular Assays