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September 23, Daan Gene announced that recently, the company obtained the State Drug Administration issued a medical device registration certificate, specifically: medical device name: new coronavirus 2019-nCoV nucleic acid testing kit (fluorescent PCR method), registration number: National Armour Registration 20203400749.
valid from the date of ratification until 20 September 2021.
, the company has obtained the "new coronavirus 2019-nCoV nucleic acid testing kit (fluorescent PCR method)" medical device registration certificate, the product and the company's February 2, 2020 announcement of the "new corona" Virus (2019-nCoV) nucleic acid testing kit (fluorescent PCR method) (registration number: National Firearms Registration 20203400063) "The main difference between the products is: (1) this kit contains a single The packaging specification of the single part of the tube, the user does not need to carry out the reaction system preparation, can directly add the sample nucleic acid after the PCR reaction, simplify the operation process; Enzymes, can shorten the detection time; (4) this kit recommends the use of the company's production of nucleic acid extraction or purification reagents (record number: Cantonese Spike equipment 20200293), simple operation can be obtained in a short period of time in the pharynx sample nucleic acid, Reduce sample detection time.
.