HiMedia Receives CDSCO certificate- Manufacturing & Sale License for COVID RT PCR KIT
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- Source: HiMedia
- Date: 19 Feb,2021
HiMedia is thrilled to announce the arrival of the much awaited CDSCO (Central Drug Standard Control Organisation- Ministry of Health, India) Manufacturing License for Sale & Distribution of Hi-PCR® Coronavirus (COVID-19) Multiplex Probe PCR Kit-MBPCR243.
HiMedia’s Molecular Biology Department has successfully obtained the permission to manufacture and distribute the “4-gene Multiplexing kit” which detects COVID-19 after facing a series of audits and rigorous documentation procedures. The Kit has been successfully validated by ICMR, NIV Pune and is ready to be sold in the market.
With Dr. Kavita Khadke’s Clinical expert opinion, it was decided that the Hi-PCR® Coronavirus (COVID-19) Multiplex Probe PCR Kit-MBPCR243 from Himedia would offer not just one, but two confirmatory genes for the Detection of COVID-19. The increasing number of repetitions in tests for low viral load samples has been an issue that pathologists have been tackling throughout the pandemic. Her valuable input led to the inclusion of both the confirmatory genes in addition to the Screening gene and Internal control, thus making it one of the very few kits with a total of four different genes in a single tube; thereby increasing the sensitivity and specificity of the kit.
1) N Gene – Nucleoprotein Gene of COVID-19
2) E Gene – Envelope protein of COVID-19
3) RdRp Gene – RNA-dependent RNA polymerase (RdRp) gene
4) RPPH1 – Internal Control
“HiMedia has achieved a major Milestone by obtaining this Crucial License for COVID RT PCR KIT. We now proudly become the only Indian Manufacturer exclusively to offer a Complete Solution and Product Range for COVID Detection i.e the “Start to End of COVID Diagnosis” which include:
• VTM- Viral Transport Medium
• COVID Viral RNA Extraction kits; both Manual and Pre-filled ready to use Automated kits which are based on Column and Magnetic Bead Based Principles
• Hi-PCR® Coronavirus (COVID-19) Multiplex Probe PCR Kit-MBPCR243.
• InstaQ® Series of Real Time PCR Machines
• InstaNX® Series of Automated Nucleic Acid Extraction Systems (InstaNX®, InstaNX® Mag32, InstaNX® Mag96)
Says the proud Director of Molecular Biology at HiMedia Labs. Pvt. Ltd., Dr. Rajas Warke, PhD Virology and Immunology, Massachusetts, USA and MBA, S. P. Jain Institute of Management, Mumbai.
Please visit our website www.himedialabs.com for more details about HiGenoMB® products related COVID Molecular testing.
About HiMedia Laboratories Pvt. Ltd.
HiMedia 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 Pvt. Ltd. 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.