DiaSys wishes to announce that we have achieved another milestone in the Indian IVD Industry. On the completion of 7 successful years, we would like to take this occasion to embrace each one of you for being an earnest part of DiaSys Diagnostics India Private Limited.
On 13th August 2021, we inaugurated our new Regional Office. We started the day with a Ganapathi Pooja at our office, to offer our prayers to the almighty and seek the blessings.
The celebration of the 75th Independence Day, was done in a very unique style at DiaSys India.
The new DiaSys reagent Procalcitonin FS is a fluid-stable, particle enhanced immunoturbidimetry assay, providing a convenient workflow on clinical chemistry analysers.
Measuring range from 0.2 ng/mL to 50 ng/mL.
QDx UriLyzer100 Pro - A semi-automated, rapid, reliable, robust solution for routine urine analysis.
QDx UriLyzer100 Pro is a trusted system for laboratories, hospitals and doctor’s clinic.
The analyzer in combination with urine test strips QDx Urine10 Pro provides pertinacious, efficient and high quality test results.
DiaSys India successfully commences pre-marketing activities of the most awaited product in DiaSys portfolio. We are in the process to launch “World’s First Truly Modular Electrolyte Analyzer” in a couple of weeks.
The evaluation of the product was successfully conducted at 4 different locations, namely Clinitech Computerized Laboratory, UDC Laboratory in the Mumbai region, Palliwal Diagnostics, Kanpur & Charak Diagnostics, and Lucknow. We received an overwhelming response from all four centers.
QDx Instalyte is a patented* product which is conceptualized, designed, developed and manufactured by R&D team at DiaSys India.
Its features are as follows:
• All in One Universal Cartridge*
• Zero Maintenance
• ISE Technology
*patent no. 33904
DiaSys India has been awarded the certificate of ICMED 13485; Certificate Registration Number 9940000025, on 8th April 2020, for its Mahape, Navi Mumbai facility.
The audit was carried out by TUV SUD South Asia- the first certification body in India to be accredited by NABCB for certifying Medical Devices Organization under ISO 13485 and ICMED Scheme.
TUV SUD South Asia awarded this certificate to DiaSys India under the scope of “Manufacturing & Distribution of In-Vitro Diagnostic Products (Biochemistry & Hematology Reagents, Rapid Test Strips and Analyzers).
DiaSys India is one among the only five IVD companies in India today to be certified for the ICMED 13485.
QDx InstaLyte- World’s First Truly Modular Electrolyte Analyzer gets awarded as the “Most Innovative Product of the Year” at the 10th MT India Healthcare Awards 2020 hosted by Medical Fair 2020 in Mumbai. It is one of the biggest platform in India where innovative products across IVD industry are screened through multiple rounds and the winner is awarded as “Most Innovative Product”. MT India Healthcare Awards is a completely unbiased platform where results are decided solely on the basis of the merits, the product possesses. The award ceremony took place on 6th March 2020 at NESCO, Mumbai in the presence of Key opinion leaders across In-vitro diagnostics Segment. A proud moment for the entire DiaSys Group as DiaSys India receives this prestigious award for the year 2020.
DiaSys India has been awarded the EN ISO13485:2016 QMS certificate on 10th February 2020, for its Mahape, Navi Mumbai facility. The audit was extensively carried out by TUV SUD South Asia under the scope of “Manufacturing & Distribution of In-Vitro Diagnostic Products (Biochemistry & Hematology Reagents, Rapid Test Strips) and Analyzers”. DiaSys India will also soon be among the only five IVD companies in India today who have certified for the ICMED 13485, the Indian Certification for Medical Devices (ICMED) -Quality Management systems for regulatory purposes. TUV SUD South Asia was the certification body for this too. The ICMED 13485 certificate scheme was developed by the Government of India, its accredited certification bodies and the Indian Medical Device Industry represented by the Quality Council of India (QCI), the National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry (AIMED) respectively. This certification is based on the ISO 13485 - Medical devices – Quality management systems and is aimed to encourage Indian companies to manufacture quality medical devices and enhancing credibility and competitiveness. This certification will help our company in reaching out wider in the Indian market, and scale up our operations as it further enhances confidence among buyers.
DiaSys Diagnostics India Private Limited invites you to Medical Fair India 2020 being held at Bombay Convention and Exhibition Center, Mumbai from 5-7th March 2020.