HiMedia Laboratories Announces Receipt of CE-IVD Certifications to their COVID-19 Detection Portfolio

HiMedia Laboratories Announces Receipt of CE-IVD Certifications to their COVID-19 Detection Portfolio


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  • Source: HiMedia

  • Date: 15 Dec,2021

HiMedia Laboratories – HiGenoMB® is proud to announce that we have received CE-IVD certifications for the new additions to our COVID-19 Detection Portfolio.

“Receiving CE-IVD certifications for the triplex RT PCR kit and Dry-swab method kit are two more additions in our COVID-Diagnostics product range. CE-IVD certifications are a mark of highly innovative but regulatory compliant Research and Development being carried out at HiMedia.“ says Dr. Kavita Khadke who brings with her profound Clinical Expertise needed for Molecular Diagnostics product development at HiGenoMB®

1. Hi-PCR COVID-19 Triplex Probe PCR Kit (MBPCR255)

This Triplex kit contains 3 genes- (N) gene, RNA-dependent RNA polymerase (RdRp) gene and internal process control. With a sensitivity Limit of Detection (LoD) of <10 copies/reaction, the kit promises to be one of the best in the market for the detection of COVID-19 Virus.

2. Hi-PCR COVID-19 Detection Kit-Dry Swab method (MBT189)

This kit is an RNA Extraction- free test for COVID- 19 diagnosis which involves direct RT PCR detection of the sample with quick & minimal pre-processing steps. Cutting down on the cost and time invested in VTM sample collection and Viral RNA Extraction especially in cost restrain situations like in developing industries or to meet supply vs. demand bottle necks, this kit is the need of the hour today.

Dr. Rajas Warke, Director of Molecular Biology at HiMedia Labs. Pvt. Ltd. Proudly states “The Molecular diagnostics atmosphere prevalent today during the pandemic has allowed for many different types and variations of RT PCR kits allowing for many technologies to co-exist and flourish. We are proud to enjoy an integral space in this market now that so many such products are developed indigenously by HiMedia.”

About HiMedia Laboratories Pvt. Ltd.

HiMedia Laboratories is one of the largest Indian Biosciences company, providing solutions to over 150 countries worldwide with an all-inclusive product range catering to Microbiology, Molecular Biology, Animal Cell culture, Plant Tissue culture, Bio chemicals, Laboratory Aids, Molecular Diagnostic instruments and more. HiGenoMB® encompasses the Molecular Biology Product Range of HiMedia Laboratories comprising of DNA/RNA Extraction kits, PCR reagents, NASBA (Nucleic Acid Sequence Based Amplification tests), Proteomics, Molecular biology grade chemicals and buffers and Instrumentation for Research & Diagnostics. Covering major aspects of the most dynamic branches of the Life Sciences group, HiGenoMB® team strives hard to make molecular work enjoyable with its user friendly product range.

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