Newmarket Biomedical Ltd are a British company specialising in the worldwide manufacture, sale and distribution of quality in-vitro diagnostic (IVD) reagents and test kits.
We specialise in serological syphilis antibody detection, namely:
Product can be supplied in a number of formats:
We were established in 2011 by a group of innovative, experienced individuals with a goal to providing high quality diagnostic kits to all areas of the scientific industry. We produce quality products which are matched by the professionalism of the staff and are complemented by our in-depth knowledge of the market.
We believe the company's success is built on its scientific base and its commitment to providing quality products with first-rate customer service.
NewBio is ISO 13485 Certified. The products are CE marked under the European In-Vitro Diagnostic Directive 98/79/EC and Regulation (EU) 2017/746 (IVDR).
Our laboratories are based in Kentford, Newmarket, Suffolk and we distribute worldwide.
We are very pleased to announce that we have received an EU Quality Management System Certificate under Regulation (EU) 2017/746 (IVDR). This certificate covers our NewBio TPHA and NewBio RPR product ranges (class C devices).
We will be transitioning to supply IVDR labelled products to our distributors and customers over the coming months so please look out for these exciting changes.
PK-TPHA product for use on PK7300 will not be certified under the IVDR. However, an updated product will be available as Class D certified for use on the PK7400 analyser through Beckman Coulter, this Certification is ongoing.
SYPHILIS EIA Total Antibody, there are no plans to certify this product under the IVDR. This product is only available on special request and a minimum order quantity will apply.
