China Virus Detection Reagent Novel Cor0navirus Detection Kit Virus Test Kit Fluorescence PCR Method Ce FDA

Introduction to Shanghai BioGerm Medical and Technology Co.,LTDBioGerm Established in March 2017,a high-tech company dedicated to the development and application of molecular diagnostic reagents for infectious pathogens.Deeply engaged in multiple fluorescent PCR diagnostic reagents and related technical services.1600 square for R&D production and quality control of diagnostic reagents,with the certification in both ISO 91001 and13485.1200 square for instrument production and sequencing.1000square medical laboratory which is already qualified for molecular genetics and microbial testing, registered level 2 biosafety laboratory equipped with ABIQ5,ABI7500, Roche CobasZ480, Bio-Rad CFX9, Slan96 and other fluorescent PCR machines, Illumina and Ion Torrent second-generation sequencers and other equipment.

Simultaneous detection of ORF1ab and NDual-target gene: The dual-target gene is designed based on the target regions of the ORF1ab and the N gene encoding the specific nucleocapsid protein.Endogenous internal standard (RNP)The internal standard uses endogenous housekeeping gene to monitor the full process from sampling and detection to avoid false negative results. Fully validatedApproved by National Institutes for Food and Drug Control (national reference product)Approved by Beijing Center for Medical Device Quality Supervision and Testing of State Food and Drug AdministrationBioGerm's 2019-nC0V Nucleic Acid Detection Kit has already tested more than 2 million specimens in China at 321 unitsRecommended by the National Health Commission of PRC

The novel c0ronavirus nucleic acid testing kit produced by BioGerm is the designated supplier for by the national health commission of PRC.