Domestic Supply of COVID-19 Test Kits
First written in FY2020. 2 of 5 entries say "Advanced", first in FY2021-Q1. Latest entry: FY2022.
0 other companies' latest entry also says "Restated".
- FY2022RestatedAnnual report
「In April 2021, the Company obtained manufacturing and marketing approval as an in vitro diagnostic and national health insurance coverage for the DetectAmp SARS-CoV-2 RT-PCR Kit, a nucleic-acid kit for detecting SARS coronavirus RNA.」
The manufacturing and marketing approval and national health insurance coverage obtained for the DetectAmp SARS-CoV-2 RT-PCR Kit have been reposted as achievements in research and development activities. - FY2022-Q2RestatedAnnual report
「In April 2021, the Company obtained manufacturing and marketing approval as an in vitro diagnostic and national health insurance coverage for the DetectAmp SARS-CoV-2 RT-PCR Kit, a nucleic-acid kit for detecting SARS coronavirus RNA.」
The manufacturing and marketing approval and national health insurance coverage obtained for the DetectAmp SARS-CoV-2 RT-PCR Kit have been reposted as achievements in research and development activities. - FY2022-Q1AdvancedAnnual report
「In April 2021, the Company obtained manufacturing and marketing approval as an in vitro diagnostic and national health insurance coverage for the DetectAmp SARS-CoV-2 RT-PCR Kit, a nucleic-acid kit for detecting SARS coronavirus RNA.」
The DetectAmp SARS-CoV-2 RT-PCR Kit for detecting COVID-19 RNA obtained manufacturing and marketing approval and national health insurance coverage in April 2021. - FY2021-Q1AdvancedAnnual report
「In June 2020, saliva was additionally approved as a specimen type for the 2019-nCoV Detection Fluorescent Real-Time RT-PCR Kit, which obtained Japan’s first marketing approval as an in vitro diagnostic for a COVID-19 test kit in March 2020. Saliva testing also became eligible for coverage under the national health insurance system.」
Saliva was additionally approved as a specimen type for Japan’s first COVID-19 test kit, and saliva testing also became eligible for coverage under the national health insurance system. - FY2020First statedAnnual report
「In addition, to help prevent the spread of COVID-19, the Company obtained manufacturing and marketing approval in March 2020 for Japan’s first COVID-19 test kit, the 2019-nCOV Detection Fluorescent Real-Time RT-PCR Kit. The product had already been supplied to more than 50 countries by BGI Genomics, and the Company made it available to clinical sites in Japan after entering into a basic sales agency agreement.」
The Company obtained Japan’s first manufacturing and marketing approval for a BGI Genomics test kit in March 2020 and supplied it to clinical sites in Japan through a basic sales agency agreement.